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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

Clinicaltrials.gov identifier NCT03925740

Recruitment Status Active, not recruiting

First Posted April 24, 2019

Last update posted April 9, 2020

Study Description

Brief summary:

Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.

  • Condition or Disease:Prevention
  • Intervention/Treatment: Drug: PreviDent Varnish
    Drug: 1.23% APF
    Drug: MI Varnish
  • Phase: Phase 4
Detailed Description

The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: September 2020
Arms and interventions
Arm Intervention/treatment
Experimental: MI Varnish Group
The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits.
Drug: MI Varnish
Application of MI varnish material versus the standard 1.23% APF.
Experimental: PreviDent Varnish Group
The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits.
Drug: PreviDent Varnish
Application of PreviDent Varnish material versus the standard 1.23% APF.
Active Comparator: 1.23% APF Control Group
Regular application of APF for 4 minutes with high volume suction to the whole mouth.
Drug: 1.23% APF
Standard 1.23% APF application
Outcome Measures
  • Primary Outcome Measures: 1. Radiographic outcome [ Time Frame: 1 year ]
    Incipient lesions either remained the same or worsened.
  • Secondary Outcome Measures: 1. Clinical examination [ Time Frame: 1 year ]
    Lesion cavitation
Eligibility Criteria
  • Ages Eligible for Study: 7 to 10 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Patient is 7-10 mixed dentition

2. Patients with any incipient non cavitated posterior proximal caries

3. Patients with any incipient non cavitated anterior proximal cariesanterior

4. ICDAS Score 1 or 2

Exclusion Criteria:

1. Any patients with any serious chronic medical problem.

2. caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity

3. history of proximal restorations

4. history of resin infiltrate

5. ICDAS score of proximal caries more than two clinically or radiographically.

Contacts and Locations
Contacts
Locations

Saudi Arabia, Makkah
King Adbulaziz University Dental Hospital
Jeddah

Sponsors and Collaborators

King Abdulaziz University

Investigators

Principal Investigator: Heba J Sabbagh, PHD King Abdulaziz University

More Information
  • Responsible Party: King Abdulaziz University
  • ClinicalTrials.gov Identifier: NCT03925740 History of Changes
  • Other Study ID Numbers: KAUFDNHelal
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 9, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by King Abdulaziz University: caries
    PreviDent varnish
    Fluoride
    1.23% APF Fluoride
    interproximal caries
    MI varnish