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LT Comparative Effectiveness of 2 Caries Treatments

NCT07213661 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-11-13

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

DEVICE

A "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

DEVICE

A "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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Suchitra S Nelson, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2030-01-31
Completion
2030-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213661 on ClinicalTrials.gov