Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol
Background. The Denture-related stomatitis (DS) is a chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganism held together by a mucus-like a matrix of carbohydrate that adheres to different surfaces, including 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
... that address this oral condition with cardiovascular complications are necessary for clinical decision-making. Material/design. A clinical trial, randomized, double-blind, of parallel groups, will be conducted in Brazil and the sample will be composed of 100 patients without teeth in both arches, users of at least maxillary complete dentures, diagnosed with DS that will be allocated in groups (n=25), 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 prostheses in lactose monohydrate; (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 Denture-related Stomatitis, removal of biofilm, reduction of microbial load (CFU), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein level -CRP, viscosity, pH and salivary flow (locally); qualitative analysis patient-centred will also be held. Measurements will be performed in the Baseline and ten days after the interventions. The results obtained will be submitted to the pertinent statistical analysis with a level of significance of 0.05. Discussion. This study will provide a guideline of clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may 4 provide evidence of correlation of oral manifestation with cardiac risk.