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LT Comparative Effectiveness of 2 Caries Treatments

RecruitingNAAges 62 Years - anyAllCase Western Reserve University
NCT07213661 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. C

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📋 Eligibility rules (as published)
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
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What it tests

  • A "simple medical strategy" consisting of silver diamine fluoride (SDF)
  • A "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)
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Where

1 site
Case Western Reserve University
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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