Background: Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matrix of carbohydrate that adheres to different surfaces, including the denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and randomized clinical trials that address this oral condition with cardiovascular complications are important in clinical decision-making.
Material/design: A clinical trial, randomized, double-blind, and with parallel groups, will be conducted in Brazil The sample will consist of 100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS, who will be allocated to groups (n = 25 per group) according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis will also be undertaken. Measurements will be performed at baseline and 10 days after the interventions. The results obtained will be statistically analyzed as pertinent, with a level of significance of 0.05.
Discussion: This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk.
Trial registration: Brazilian Registry of Clinical Trials, RBR-4hhwjb. Registered on 9 November 2018.
Keywords: Biofilm; Candida; Cleansers; Clinical trials; Complete dentures; Heart diseases; Stomatitis.