Adjunct Clinical Assistant Professor/ Medicaid Dental Policy Specialist University of Michigan School of Dentistry/ Michigan Department of Health and Human Services
Disclosure(s):
Elizabeth I. Pitts, RDH, MS: No financial relationships to disclose
Description: The aim of this study was to evaluate the success in recruitment prior to COVID-19 of parent/child pairs in a randomized clinical trial (RCT) to test the effectiveness of Silver Diamine Fluoride (SDF) in arresting cavitated caries lesions in the primary dentition in the U.S. Data collected over a 16-month period at the University of Michigan, New York University, and University of Iowa were analyzed. Comparisons were made using pair-wise Fisher’s Exact tests. Additionally, reasons for declining participation were analyzed. Following screenings, 990 potentially eligible parent/child pairs were identified. A total of 896 (91%) were approached, of which 354 (40%) were enrolled in the SDF trial. The success in enrollment from different sites was as follows (% of total approached at the site; % of successful enrollment at the site): Head Starts (88%; 33%), FQHCs (96%; 37%), medical/dental clinics (91%; 53%), WIC programs (92%; 43%), health department (100%, 29%), public school (100%, 8%), and other (100%; 47%). The rates of approached vs. not approached and enrolled vs. not enrolled significantly varied across sites (p< 0.05 for both by Fisher’s Exact test with Monte Carlo simulation). Although the overall “approach” p-value was significant, none of the pair-wise tests were significant. For “enrolled,” medical/dental clinics were significantly higher than Head Starts and public schools, and FQHC and WIC were significantly higher than public schools (all p< 0.05). Of participants who declined (n=171), 50% preferred regular dental care over participating in a clinical trial. Medical/dental clinics yielded the greatest enrolled participants for recruitment.
Source of Funding:: This study is supported by National Institutes of Health Grant 1U01DE027372.