LT Comparative Effectiveness of 2 Caries Treatments

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.

Primary Outcome

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.

Conditions Studied

Interventions

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

Study Locations (1)