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LT Comparative Effectiveness of 2 Caries Treatments

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2025 to Oct 8, 2025
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07213661
Lead Sponsor Case Western Reserve University
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)
Dental Caries
Related terms Dental Caries, Tooth Loss
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov