Nelson Suchitra, Albert Jeffrey M, Milgrom Peter
Case Western Reserve University, Cleveland, OH, United States.
Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.
JMIR Res Protoc. 2020 Sep 8;9(9):e17840. doi: 10.2196/17840.
The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults.
This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish.
A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023.
This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings.
ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17840.
老年人的大多数龋齿病变位于牙龈线处、补牙和牙冠边缘以及牙龈退缩后的牙根表面。这些病变难以通过使用牙钻的传统手术治疗进行修复，修复往往会失败。临床指南较为笼统，在老年人的牙科护理中应用的是为年轻人设计的治疗方法。
本研究将比较两种循证非手术策略对62岁及以上成年人龋齿病变的治疗效果：（1）每半年局部应用一次氟化银胺与（2）非创伤性修复治疗+每半年涂一次氟化漆。
在22个公共补贴和其他低收入住房设施/场所进行一项整群随机临床试验（第1组：11个场所，275名参与者；第2组：11个场所，275名参与者）。在基线时，对参与者进行龋齿病变筛查。患有非紧急病变的参与者将根据住房场所随机分配到的治疗组进行治疗。主要结局指标为治疗后52周时的龋齿病变停止进展、牙齿敏感和牙痛。主要目的的分析方法包括采用广义估计方程法来确定氟化银胺相对于非创伤性修复治疗+氟化漆治疗的非劣效性。
该试验于2019年4月获得资助。2019年9月开始招募参与者，预计2023年6月得出结果。
本研究将为老年人龋齿病变的治疗护理标准提供依据。如果有效，这些干预措施中的任何一种在临床和社区环境中都具有广泛的适用性。
ClinicalTrials.gov NCT03916926；https://clinicaltrials.gov/ct2/show/NCT03916926。
国际注册报告识别码（IRRID）：DERR1-10.2196/17840。
