Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial
Article [Accepted Manuscript]
Abstract(s)
Background: Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every
three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health professionals,
based on the belief that colonization by Candida spp. is the main cause of DES. However, high recurrence rates and
adverse effects are commonly observed, prompting the need for practice guidelines regarding treatment. Results from
our pilot study demonstrate that palatal brushing can reduce the palatal inflammation and potentially associated Candida
carriage without any need for antifungal therapy. The objective of this study is to validate these pilot results by means of
a randomized controlled trial (RCT) and provide a practice guideline for clinicians.
Methods/design: A pragmatic, two-parallel-arm, multicenter RCT will be conducted in Canada, Brazil, and Chile. Fifty-two
adult complete denture wearers presenting with moderate to severe DES will be allocated randomly to two groups: the
Intervention arm will consist of palatal brushing and standard oral and denture hygiene measures, while the Control arm
will include only standard oral and denture hygiene measures. The study outcome will be the oral Candida carriage.
Participants will be assessed at baseline, and at 3 and 6 months post intervention. Descriptive, bivariate, and mixed
models with repeated measures will be performed following the intention-to-treat principle.
Discussion: This pragmatic RCT will serve to provide a clinical practice guideline regarding the use of preventive
measures in the treatment of biofilm-mediated oral diseases. Moreover, it will have a great impact on reducing the
harm of antifungal overtreatment on patients suffering from DES.
Other location(s)
Collections
This document disseminated on Papyrus is the exclusive property of the copyright holders and is protected by the Copyright Act (R.S.C. 1985, c. C-42). It may be used for fair dealing and non-commercial purposes, for private study or research, criticism and review as provided by law. For any other use, written authorization from the copyright holders is required.