Long-term comparison of two treatments for tooth decay in older adults
Official title: Long-term Comparative Effectiveness of 2 Treatments to Arrest Dental Caries in Older Adults
Run by Case Western Reserve University · NCT07213661 · Data updated 2026-11-12
This project will test whether twice-yearly silver diamine fluoride works as well as atraumatic restorative treatment with fluoride varnish for preventing and treating tooth decay in older adults who participated in a prior housing-based study in Northeast Ohio.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 62 Years and up |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | November 13, 2025 |
| Trial ID | NCT07213661 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are original participants from the 33 subsidized housing sites who provide informed consent and are willing to remain in the one-year long-term follow-up in Northeast Ohio.
✕Probably not a fit
People with known sensitivity to silver or heavy metals, those with serious life‑threatening medical disease, or those with active oral ulceration/abscess (until resolved) may not benefit or be eligible to participate.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This long-term follow-up continues a cluster randomized trial carried out in 33 subsidized housing sites in three Northeast Ohio counties, comparing biannual 38% silver diamine fluoride (SDF) to atraumatic restorative treatment (ART) with glass ionomer plus biannual fluoride varnish (FV). About 480 original participants (287 SDF, 193 ART+FV) will contribute data at 3 to 6 years from their original randomization and will be followed for one year in this extension. Participants will receive the assigned intervention when new decay is present, and primary outcomes are clinical measures and questionnaire-based oral health quality of life tested for noninferiority of SDF versus ART+FV. Participants are blinded to arm assignment while clinical staff cannot be fully blinded because of the nature of the treatments.
Why it matters
Potential benefit: If SDF proves noninferior, it could offer a simpler, less-invasive, and lower-cost alternative to conventional restorations that helps prevent tooth loss in older adults.
How similar studies have gone: Previous studies have shown SDF can arrest caries and ART+FV is an established restorative approach, but direct long-term head-to-head data in older adults living in subsidized housing remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Case Western Reserve University
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Suchitra S Nelson, PhD — Case Western Reserve University
- Study coordinator: Suchitra S Nelson, PhD
- Email: sxn15@case.edu
- Phone: 216-368-3469
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.