CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Palatal brushingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02686632
NCT02686632N/ACompleted

Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial

Université de Montréal·interventional·Posted Feb 19, 2016·Updated May 2, 2018

In Brief

A clinical study evaluating Palatal brushing for Denture Stomatitis. Completed, enrolled 52 participants across 1 site.

Detailed Summary

Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers. The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common. The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsMcGill University

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 19, 2016
Enrollment StartSep 1, 2016
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.4 years ago

Interventions

Palatal brushingbehavioral

Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.