LT Comparative Effectiveness of 2 Caries Treatments

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07213661
Status
Recruiting
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Conditions

  • Dental Caries

Eligibility Criteria

Sex
ALL
Age
62 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 8, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A "simple medical strategy" consisting of SDF
    This treatment will be a bi-annual application of 38% silver diamine (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) solution to new ICDAS lesions code 3-6 (at baseline and 26-weeks or 26-weeks and 52 weeks) following manufacturers instructions and guidelines published by UCSF (2016).
  • Active Comparator: A "typical dental strategy" consisting of ART + FV
    Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006),2 and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.

Primary Outcome Measure

Caries Arrest Rate [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Suchitra S Nelson, PhD
[email protected]
216-368-3469
Suchitra S Nelson, PhD (PRINCIPAL_INVESTIGATOR)

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Case Western Reserve University· Cleveland, OH

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