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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

Clinicaltrials.gov identifier NCT03943095

Recruitment Status Completed

First Posted May 9, 2019

Result First Posted September 11, 2020

Last update posted September 11, 2020

Study Description

Brief summary:

This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

  • Condition or Disease:Dentin Hypersensitivity
    Dentin Sensitivity
  • Intervention/Treatment: Other: Potassium Nitrate
    Other: Stannous Fluoride
  • Phase: Phase 2
Detailed Description

This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 123 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Test Dentifrice
Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 5 % weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing.
Other: Potassium Nitrate
The test dentifrice contains 5% w/w potassium nitrate.

Other: Stannous Fluoride
The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
Active Comparator: Control Dentifrice
Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing.
Other: Stannous Fluoride
The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
Outcome Measures
  • Primary Outcome Measures: 1. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) [ Time Frame: Baseline (Day 0) ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 2. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3 [ Time Frame: Day 3 ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 3. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7 [ Time Frame: Day 7 ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 4. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14 [ Time Frame: Day 14 ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 5. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28 [ Time Frame: Day 28 ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 6. Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56 [ Time Frame: Day 56 ]
    Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 7. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0) [ Time Frame: Baseline (Day 0) ]
    Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 8. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3 [ Time Frame: Day 3 ]
    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 9. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7 [ Time Frame: Day 7 ]
    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 10. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14 [ Time Frame: Day 14 ]
    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 11. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28 [ Time Frame: Day 28 ]
    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 12. Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56 [ Time Frame: Day 56 ]
    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
  • 13. Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline) [ Time Frame: Baseline (Day 0) ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • 14. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3 [ Time Frame: Day 3 ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • 15. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7 [ Time Frame: Day 7 ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • 16. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14 [ Time Frame: Day 14 ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • 17. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28 [ Time Frame: Day 28 ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • 18. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56 [ Time Frame: Day 56 ]
    Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
  • Secondary Outcome Measures: 1. Change From Baseline in Schiff Sensitivity Score at Day 56 [ Time Frame: Baseline (Day 0), Day 56 ]
    Evaporative air sensitivity was assessed on the facial surfaces of teeth by directing one second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from a distance of approximately 1 cm. Participant response to stimulus was evaluated using Schiff sensitivity scale following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3;a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline are derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable.
  • 2. Change From Baseline (Day 0) in Tactile Threshold on Day 56 [ Time Frame: Baseline (Day 0), Day 56 ]
    Tactile sensitivity was assessed for eligible teeth using constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until tactile threshold for that visit is reached. The probe tip was placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant was asked whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gives two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20g;at all subsequent visits,80g.If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (Baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline are derived from ANCOVA model which included treatment as factor and baseline tactile senstivity as covariate with change from baseline as dependent variable.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Participant provision of a signed and dated informed consent document indicating that
the participant has been informed of all pertinent aspects of the study before any
assessment is performed

- Participant who is willing and able to comply with scheduled visits, treatment plan,
and other study procedures

- Participant in good general, oral and mental health with, in the opinion of the
investigator or medically qualified designee, no clinically significant/relevant
abnormalities in medical history, or upon oral examination, or condition that would
impact the Participant's safety, wellbeing or the outcome of the study, if they were
to participate in the study, or affect the individual's ability to understand and
follow study procedures and requirements

- Male participant able to father children or female participant of child-bearing
potential and at risk for pregnancy must agree to use a highly effective method of
contraception throughout the study and for at least 5 days after the last dose of
assigned treatment

- AT VISIT 1 (Screening): Participant must have

1. a self-reported history of dentin hypersensitivity (DH) lasting more than six
months but not more than 10 years

2. a minimum of 20 natural teeth

3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars),
preferably in different quadrants, with clinically diagnosed DH; each tooth must
meet the following criteria:

- exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)

- Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin)
only

- Clinical mobility less than or equal to (=<) 1 - DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity (tactile threshold [==] 2)

- AT VISIT 2 (Baseline):

Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines,
pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile
and evaporative air sensitivity (each tooth must have a tactile threshold (==) 2) at the Screening and Baseline visits

Exclusion Criteria:

- Participant who is an employee of the investigational site, either directly involved
in the conduct of the study or a member of their immediate family; or an employee of
the investigational site otherwise supervised by the investigator; or a
GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct
of the study or a member of their immediate family

- Participant who has participated in other studies (including non-medicinal studies)
involving investigational product(s) within 30 days prior to study entry and/or during
study participation

- Participant with, in the opinion of the investigator or medically qualified designee,
an acute or chronic medical, oral, psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the investigator or medically qualified designee, would make the
participant inappropriate for entry into this study

- Participant with any condition which, in the opinion of the investigator or medically
qualified designee, causes xerostomia

- Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test
[UPT] at Screening)

- Participant who is a breast-feeding female

- Participant with known or suspected intolerance or hypersensitivity to the study
materials (or closely related compounds) or any of their stated ingredients

- Participant with a recent history (within the last year) of alcohol or other substance
abuse

- Participant who has participated in another tooth desensitizing treatment study within
8 weeks Screening

- Participant who has used an oral care product indicated for the relief of DH within 8
weeks of Screening (participant will be required to bring their current oral care
products to the site in order to verify the absence of known anti-sensitivity
ingredients)

- Participant who has had dental prophylaxis within 4 weeks of Screening

- Participant who has had a tooth bleaching procedure within 8 weeks of Screening

- Participant who has had treatment for periodontal disease (including surgery) within
12 months of Screening

- Participant who has had scaling or root planning within 3 months of Screening

- Participant with gross periodontal disease

- Participant with evidence of gross intra-oral neglect or the need for extensive dental
therapy

- Participant with a tongue or lip piercing or presence of multiple dental implants

- Participant with fixed or removable partial dentures

- Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic
retainer

- SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':

1. Tooth with evidence of current or recent caries or reported treatment of decay
within 12 months of Screening

2. Tooth with exposed dentin but with deep, defective or facial restorations

3. Tooth with full crown or veneer

4. Sensitive tooth with contributing etiologies other than erosion, abrasion or
recession to exposed dentin

5. Sensitive tooth not expected to respond to treatment with an over-the-counter
dentifrice in the opinion of the investigator

- Participant taking daily doses of medication/treatments which, in the opinion of the
investigator or medically qualified designee, could interfere with the perception of
pain (examples of such medications include analgesics, anticonvulsants, antihistamines
that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants,
mood-altering and anti-inflammatory drugs)

- AT VISIT 1 (Screening):

Participant who has taken antibiotics in the 2 weeks prior to the Screening visit

- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the
Baseline visit, during the acclimatization period

- Participant taking daily doses of a medication which, in the opinion of the
investigator or medically qualified designee, is causing xerostomia

- Participant who requires antibiotic prophylaxis for dental procedures

- Participant who has previously been enrolled in this study

- Participant who, in the opinion of the investigator or medically qualified designee,
should not participate in the study

Contacts and Locations
Contacts
Locations

Canada
GSK Investigational Site
Mississauga

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

More Information
  • Responsible Party: GlaxoSmithKline
  • ClinicalTrials.gov Identifier: NCT03943095 History of Changes
  • Other Study ID Numbers: 209723, 209723
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: September 11, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Dentin Sensitivity Hypersensitivity
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Double;Primary Purpose: Treatment
  • Condition: Dentin Hypersensitivity<br/>Dentin Sensitivity
  • Interventions : Other: Potassium Nitrate
    Other: Stannous Fluoride
  • Enrollment: 123
Participant flow
Recruitment Details Participants were recruited from one center in Canada
Pre-assignment Details A total of 123 participates were screened and enrolled, out of which 104 participants were randomized in the study and 19 participants were not randomized.
Arm/Group title Control Dentifrice Test Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily. Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
Period Title: Overall Study
Started 52 52
Completed 51 51
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject 1
Incorrectly dispensed wrong box kit 1
Baseline Characteristics
Arm/Group title TotalControl DentifriceTest Dentifrice
Arm/Group Description Total of all reporting groupsParticipants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
Overall Number of Baseline Participants 1045252
Baseline Analysis Population Description The Safety Population included all randomized participants who received at least one dose of study product.
Outcome Measures
1. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Day 56
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of Sensitive teeth
1.3
0.5
2. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Day 28
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of Sensitive teeth
2.1
1.0
3. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Day 14
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of Sensitive teeth
2.8
1.7
4. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Day 7
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of Sensitive teeth
3.2
2.2
5. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Day 3
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of Sensitive Teeth
3.6
3.6
6. PrimaryOutcome
Title Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Description Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame Baseline (Day 0)
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Number of sensitive teeth
3.2
3.1
7. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Description Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 56
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
64.80
79.71
8. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Description Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 28
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
57.94
71.67
9. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Description Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 14
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
48.53
60.59
10. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7
Description Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 7
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
38.75
47.45
11. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Description Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 3
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
27.98
31.35
12. PrimaryOutcome
Title Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Description Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Baseline (Day 0)
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
12.31
11.06
13. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 56
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
0.42
0.12
14. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 28
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
0.75
0.32
15. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 14
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
1.07
0.52
16. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 7
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
1.20
0.73
17. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Day 3
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
1.46
1.19
18. PrimaryOutcome
Title Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Description Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Time Frame Baseline (Day 0)
Outcome Measure Data
Analysis Population Description
A modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
2.60
2.61
19. SecondaryOutcome
Title Change From Baseline (Day 0) in Tactile Threshold on Day 56
Description Tactile sensitivity was assessed for eligible teeth using constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until tactile threshold for that visit is reached. The probe tip was placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant was asked whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gives two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20g;at all subsequent visits,80g.If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (Baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline are derived from ANCOVA model which included treatment as factor and baseline tactile senstivity as covariate with change from baseline as dependent variable.
Time Frame Baseline (Day 0), Day 56
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Grams
51.94
69.34
20. SecondaryOutcome
Title Change From Baseline in Schiff Sensitivity Score at Day 56
Description Evaporative air sensitivity was assessed on the facial surfaces of teeth by directing one second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from a distance of approximately 1 cm. Participant response to stimulus was evaluated using Schiff sensitivity scale following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3;a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline are derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable.
Time Frame Baseline (Day 0), Day 56
Outcome Measure Data
Analysis Population Description
mITT population included all randomized participants who received at least one dose of study product and had at least one post-baseline efficacy measurement.Here, number analyzed indicates participants with available data for this outcome measure.
 
Arm/Group title Control DentifriceTest Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 % w/w potassium nitrate and 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.
Overall Number of Participants Analyzed 5252
Measure Type: Mean (Standard Error)
Unit of Measure: Score on a scale
-2.17
-2.48
Adverse Events
Time Frame From screening up to Day 56
Adverse Event Reporting Description Safety population: all participants who were eligible to participate in the study and received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
 
Arm/Group Title Test DentifriceControl Dentifrice
Arm/Group Description Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily.
All-Cause Mortality
  Test Dentifrice Control Dentifrice
Affected at Risk (%) Affected at Risk (%)
Total 0/52 (0.00%) 0/52 (0.00%)
Total
Total, all-cause mortality 0 /52 (0.00%) 0 /52 (0.00%)
Serious Adverse Events
  Test Dentifrice Control Dentifrice
Affected at Risk (%) Affected at Risk (%)
Total 0/52 (0.00%) 0/52 (0.00%)
Total
Total, serious adverse events 0 /52 (0.00%) 0 /52 (0.00%)
Show Other (Not Including Serious) Adverse Events
  Test Dentifrice Control Dentifrice
Affected / at Risk (%) Events Affected / at Risk (%) Events
Total 2/52 (3.85%) 1/52 (1.92%)
Gastrointestinal disorders
Oral mucosal exfoliation 2 /52 (3.85%) 2 0 /52 (0.00%) 0
Injury, poisoning and procedural complications
Mouth injury 0 /52 (0.00%) 0 1 /52 (1.92%) 1
Total
Total, other adverse events 2 /52 (3.85%) 0 1 /52 (1.92%) 0
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact
  • ClinicalTrials.gov Identifier: NCT03943095 History of Changes
  • Other Study ID Numbers: 209723
  • First Submitted: May 7, 2019
  • First Posted: May 9, 2019
  • Results First Submitted: August 20, 2020
  • Results First Posted: September 11, 2020
  • Last Update Posted: September 11, 2020