Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17840