de Souza Raphael F, Khiyani Muhammad Faheem, Chaves Carolina A L, Feine Jocelyne, Barbeau Jean, Fuentes Ramón, Borie Eduardo, Crizostomo Luciana C, Silva-Lovato Claudia H, Rompre Pierre, Emami Elham
Division of Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.
Department of Dental Materials and Prosthetics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.
Trials. 2017 May 5;18(1):211. doi: 10.1186/s13063-017-1947-y.
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.
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.
ClinicalTrials.gov, NCT02686632 . Registered on 15 February 2016.
义齿相关的红斑性口炎（DES）是一种慢性生物膜介导的疾病，每三名全口义齿佩戴者中就有一人受其影响。抗真菌药物是口腔健康专业人员最常开具的治疗药物，基于这样一种观点，即念珠菌属的定植是DES的主要病因。然而，通常观察到高复发率和不良反应，这促使需要制定有关治疗的实践指南。我们的试点研究结果表明，腭部刷牙可以减轻腭部炎症，并可能减少相关的念珠菌携带，而无需任何抗真菌治疗。本研究的目的是通过随机对照试验（RCT）验证这些试点结果，并为临床医生提供一份实践指南。
方法/设计：将在加拿大、巴西和智利进行一项实用的、双平行组、多中心RCT。52名患有中度至重度DES的成年全口义齿佩戴者将被随机分配到两组：干预组将包括腭部刷牙以及标准的口腔和义齿卫生措施，而对照组将仅包括标准的口腔和义齿卫生措施。研究结果将是口腔念珠菌携带情况。将在基线以及干预后3个月和6个月对参与者进行评估。将遵循意向性治疗原则进行描述性、双变量和重复测量的混合模型分析。
这项实用的RCT将有助于提供一份关于在生物膜介导的口腔疾病治疗中使用预防措施的临床实践指南。此外，它将对减少抗真菌过度治疗对DES患者造成的危害产生重大影响。
ClinicalTrials.gov，NCT02686632。于2016年2月15日注册。
