RecruitingNot ApplicableNCT07213661

LT Comparative Effectiveness of 2 Caries Treatments

Long-term Comparative Effectiveness of 2 Treatments to Arrest Dental Caries in Older Adults


Sponsor

Case Western Reserve University

Enrollment

480 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 62 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Case Western Reserve University

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07213661


Related Trials