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

NCT07213661 NA RECRUITING

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.

Details

Lead sponsor	Case Western Reserve University
Phase	NA
Status	RECRUITING
Enrolment	480
Start date	2025-10-08
Completion	2030-01

Conditions

• Dental Caries

Interventions

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

Primary outcomes

• Caries Arrest Rate — Baseline (LTFU 1) to 52-weeks (LTFU 3)
  ICDAS examinations are used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2) that received SDF or ART + FV treatment. A lesion is considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The overall mean will be calculated by surfaces.
• New Decay Rate — Baseline (LTFU 1) to 52-weeks (LTFU 3)
  New decay is defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on newly decayed teeth found at LFTU #1, #2 and #3 (even on surfaces that did not receive the study treatments). The overall mean of decayed surfaces will be calculated.
• Tooth Loss — Baseline (LTFU 1) to 52-weeks (LTFU 3)
  Tooth loss will be assessed through ICDAS exams by documenting absence of teeth. The overall mean will be calculated for the number of teeth lost.
• Tooth Pain — Baseline (LTFU 1) to 52-weeks (LTFU 3)
  Tooth Pain and Sensitivity will be assessed using the PROMIS v.1.0 - Pain Intensity 3a \[Modified for Dental\]. An overall mean pain intensity score will be created for the 3-item Likert scale with answers ranging from 0-no pain to 4-very severe.
• Oral Health Related Quality of Life — Baseline (LTFU 1) to 52-weeks (LTFU 3)
  Geriatric Oral Health Related Quality of Life (GOHRQoL) is an overall score created by taking the sum of each of the 12 items, which are on a Likert scale using 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The scores range from 12-36 with higher scores indicating better quality of life. The overall mean for the participant population will be calculated.

Countries

United States