Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial.

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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02686632 . Registered on 15 February 2016.