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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment

Clinicaltrials.gov identifier NCT03919942

Recruitment Status Active, not recruiting

First Posted April 18, 2019

Last update posted April 23, 2019

Study Description

Brief summary:

The objective of this study is to evaluate the clinical effect and the impact on the quality of life of the coadjuvant treatment with Oxyflower® gel in cases of pericoronitis in lower third molar, compared to chlorhexidine gel and placebo gel.

  • Condition or Disease:Pericoronitis
  • Intervention/Treatment: Other: OxyFlower gel
    Other: Chlorhexidine gel
    Other: Placebo gel
  • Phase: N/A
Detailed Description

This study consist of 51 participants diagnosed with pericoronitis who received coadjuvant treatment with gel. The participants were submitted to emergency treatment, with local debridement and irrigation with saline solution followed by topical application of the randomized gel: oxyflower®, chlorhexidine, or placebo gel. In cases of pericoronitis with systemic signs / symptoms, such as fever, malaise and lymphadenopathy, systemic antibiotic therapy was prescribed one hour before debridement, lasting seven days. All participants received oral hygiene guidelines and were instructed to apply the same gel twice daily for one week . After 30 days, it was performed tooth removal for cases in which there is not enough space for dental eruption; or distal wedge surgery when there is space for dental eruption with excessive gingiva in the distal. It was evaluated as outcomes: pain, quality of life, depth of probing, level of bone crest in the distal of second molar, buccal opening and extent of edema / erythema. A comparative analysis was performed between the groups, before and after treatment.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 51 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment: Controlled Randomized Clinical Trial
  • Actual Study Start Date: September 2017
  • Estimated Primary Completion Date: February 2018
  • Actual Study Completion Date: June 2019
Arms and interventions
Arm Intervention/treatment
Experimental: OxyFlower gel
pericoronitis treatment with oxyflower gel.
Other: OxyFlower gel
the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal
Experimental: Chlorhexidine gel
pericoronitis treatment with chlorhexidine gel.
Other: Chlorhexidine gel
the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal.
Placebo Comparator: Placebo gel
pericoronitis treatment with placebo gel.
Other: Placebo gel
the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal
Outcome Measures
  • Primary Outcome Measures: 1. Change from Baseline Quality of life [ Time Frame: baseline, 30 days ]
    Oral health related quality of life measured by questions related to the quality of life. This questionnaire comprises 14 items within 7 subscales (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, deficit).
  • 2. Change from Baseline Pain [ Time Frame: baseline, 1,3,7,15 and 30 days ]
    Post-operative pain measured by visual analogic scale (VAS). The VAS comprises a 10cm horizontal line, with no marks. When responding to a VAS, subjects specify their level of pain by indicating a position along a continuous line between two end-points. Higher values represent a worse outcome.
  • Secondary Outcome Measures: 1. Change from Baseline trismus [ Time Frame: baseline, 1,3,7,15 and 30 days ]
    maximum mouth opening measured as maximum distance between incisal edges of upper and lower central incisors.
  • 2. change from edema / erythema [ Time Frame: baseline, 1, 3, 7, 15 and 30 days ]
    The extent of edema / erythema was assessed by measuring the greater vestibulo-lingual and mesio-distal distance of the lesion, by periodontal probe.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 35 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- signs / symptoms of pericoronitis with

- spontaneous pain

- ASA I or II

- Consent to participate

Exclusion Criteria:

- Periodontal status level IV

- Smokers

- antibiotic therapy in the last 2 months

Contacts and Locations
Contacts
Locations

Brazil, Minas Gerais
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina

Sponsors and Collaborators

Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

Principal Investigator: Patricia F Gonçalves, PhD Federal University of the Valleys of Jequitinhonha and Mucuri

More Information
  • Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
  • ClinicalTrials.gov Identifier: NCT03919942 History of Changes
  • Other Study ID Numbers: 16042019
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri: Quality of life
    Pericoronitis
    Phytotherapy
  • Additional relevant MeSH terms: Pericoronitis