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LT Comparative Effectiveness of 2 Caries Treatments
Long-term Comparative Effectiveness of 2 Treatments to Arrest Dental Caries in Older Adults
Who can join
Ages 62 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: * Were participants in the original study from the 33 housing sites * Provide signed and dated long-term follow-up informed consent form * Willingness to stay in the LTFU study for 1 year * Additionally for focus groups, completed the treatment phase of the study Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Sensitivity to silver or other heavy-metal ions * Serious life-threatening medical disease * Additionally, any participant with the presence of gingival/perioral ulceration or stomatitis or tooth abscess in any specific tooth will be referred to a dentist but can only be enrolled after resolution
About the study
This study is a continuation of a cluster randomized clinical trial (cRCT) conducted in 33 publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The Intervention Arm (18 sites) - participants received biannual silver diamine fluoride (SDF) versus the Control Arm (15 sites) where participants received atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 568 participants were recruited in the original study, and 480 participants (Intervention Arm: 287, Control Arm: 193) are expected to continue in this long-term follow-up study. Since enrollment in the original study was done over time, each participant will contribute data at 3 to 6 years (from randomization) in the LTFU depending on study entry to assess clinical equipoise of the two treatments.
Community-dwelling older adults, regardless of medical, cognitive, or motor impairments, were considered for inclusion in the original study and were: (1) aged ≥ 62 years in the 33 housing facilities; (2) have at least one untreated active root or coronal carious lesion with ICDAS-II lesion severity code of 3 or greater ; (3) willingness to stay in the study for 1 year. Exclusion criteria: (1) sensitivity to silver or other heavy-metal ions; (2) serious life-threatening medical disease. Additionally, any participant with the presence of gingival/perioral ulceration or stomatitis or tooth abscess in any specific tooth were referred to a dentist and enrolled after resolution. The LTFU study will follow the same enrolled participants long-term. The current mean (sd) age of the 480 participants who will enter the LTFU study will be 73.73 (6.92) years.
What is being tested
- A "simple medical strategy" consisting of silver diamine fluoride (SDF) (device)
- A "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV) (device)
Sponsor: Case Western Reserve University · Participants: 480 · Started: Oct 8, 2025
Contact the study team
- Suchitra S Nelson, PhD · Phone: 216-368-3469
- Shelley Curtan, MEd · Phone: 216-368-3968
Official record on ClinicalTrials.gov — NCT07213661
Locations in the U.S.
| Ohio | Case Western Reserve University, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.