NCT07213661 LT Comparative Effectiveness of 2 Caries Treatments
| NCT ID | NCT07213661 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2025-10-08 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Suchitra S Nelson, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT07213661 clinical trial?
This trial is open to participants of all sexes, aged 62 Years or older, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213661 currently recruiting?
Yes, NCT07213661 is actively recruiting participants. Contact the research team at sxn15@case.edu for enrollment information.
Where is the NCT07213661 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07213661 clinical trial?
NCT07213661 is sponsored by Case Western Reserve University. The principal investigator is Suchitra S Nelson, PhD at Case Western Reserve University. The trial plans to enroll 480 participants.