Long-term Comparative Effectiveness of 2 Treatments to Arrest Dental Caries in Older Adults
Case Western Reserve University
Summary
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.
Description
Study Design: The original design was a cluster randomized clinical trial (RCT) in 33 publicly subsidized housing facilities/sites in NE Ohio and housing sites randomized into 2 arms in a roughly 1:1 ratio (SDF vs. ART + FV) and is a continuation of the original study "Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments". All participants will be followed for one year and will receive intervention when new decay is present. The study hypothesis for the LTFU study is noninferiority of SDF to ART + FV for each of the primary outcomes. Primary outcomes are…
Eligibility
- Age range
- 62+ years
- Sex
- All
- Healthy volunteers
- Yes
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 dis…
Interventions
- DeviceA "simple medical strategy" consisting of silver diamine fluoride (SDF)
Bi-annual topical application of 38% silver diamine solution to new ICDAS lesions code 3-6. Advantage Arrest, Elevate Oral Care, West Palm Beach FL
- DeviceA "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)
GC Fuji (for ART) and FluoriMax Varnish. Atraumatic Restoration Treatment (ART) to new ICDAS lesions code 3-6, followed by bi-annual topical fluoride varnish (FV) to all teeth.
Location
- Case Western Reserve UniversityCleveland, Ohio