Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 16, 2020
Date Accepted: Jul 19, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparative Effectiveness of Two Non-Surgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Design of a Cluster Randomized Trial
ABSTRACT
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 two evidence-based non-surgical strategies to manage dental caries lesions in older adults ≥ 62 years: (1) bi-annual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + bi-annual 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 non-urgent 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, tooth pain at 52 weeks post-treatment. Analytic methods for the primary aim include a generalized estimating equations (GEE) approach to determine ‘non-inferiority’ of SDF relative to ART+FV treatment.
Results:
Enrollment began in Fall of 2019 and results are expected in June of 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. Clinical Trial: NCT03916926
Citation
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