The Use of Silver Fluoride for Oral Health and Well-Being in Aged Care Residents: Protocol for a Cluster Randomized Controlled Trial.

Background: Older adults living in residential aged care facilities (RACFs), particularly in regional and rural areas, experience a high burden of untreated dental caries, tooth sensitivity, and oral pain. Workforce shortages, limited access to dental services, and competing health priorities make the delivery of timely oral health care challenging in these settings. Poor oral health contributes to pain, impaired nutrition, reduced quality of life, and increased health service use. There is an urgent need for context-appropriate, accessible, and cost-effective interventions for RACF residents. Aqueous silver fluoride (AgF), a minimally invasive topical agent with caries-arresting and desensitizing properties, offers a pragmatic approach suitable for aged care settings. Objective: This protocol aims to test the effectiveness of an AgF intervention package in reducing tooth sensitivity and tooth pain, arresting caries, and improving oral health and well-being in older adults living in regional and rural RACFs. Methods: This study is a 2-arm, parallel-group cluster randomized controlled trial, with RACFs as the unit of randomization. The trial is conducted in public and private RACFs across regional and rural Queensland and New South Wales, Australia. Eligible participants are residents with at least 1 natural tooth. At baseline, calibrated examiners perform standardized oral examinations to assess dental caries status, lesion activity, and dentin hypersensitivity. AgF is applied to eligible carious lesions and sensitive tooth surfaces following a standardized clinical protocol. Follow-up assessments at 3 months include a repeat clinical examination to assess caries arrest and changes in hypersensitivity, along with resident-reported measures of oral pain and oral health-related quality of life collected using validated instruments. Outcomes include change in tooth sensitivity and oral pain at the 3-month follow-up, caries arrest rates, and change in oral health-related quality of life. Analyses will follow intention-to-treat principles and account for clustering using mixed-effects regression models with facility-level random effects. Models will adjust for baseline covariates and prespecified confounders. Sensitivity analyses will examine the robustness of the findings. The trial will also inform a planned economic evaluation embedded within the broader research program. Results: This trial forms part of a broader program funded by the Medical Research Future Fund Dementia, Aging and Aged Care Grant (2024439). Recruitment and data collection commenced in May 2025 and are expected to conclude in June 2026. Recruitment is ongoing across participating RACFs. Data analysis is expected to commence in mid-2026, with primary findings anticipated for publication in early 2027. Conclusions: This protocol outlines a rigorous evaluation of a minimally invasive, scalable oral health intervention tailored to RACF settings. The findings will provide high-quality evidence on effectiveness to inform policy, service delivery, and economic evaluation aimed at improving oral health and well-being among older adults in residential aged care.