Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments

Detailed Summary

The study is a cluster randomized clinical trial (RCT) to be conducted in 40 (22 originally planned +16 additional) publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The facilities will be randomized to 2 arms: Arm 1 (20 sites) - Participants will receive biannual silver diamine fluoride (SDF) versus Arm 2 (20 sites): Participants will receive atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 590 (550 originally planned + 40 additional) participants (Arm 1: 295, Arm 2: 295) will be followed for one year (baseline, 26 weeks, 52 weeks). The protocol for each arm will address both coronal and root surface tooth decay lesions: Arm 1: The treatment will be bi-annual topical 38% SDF(Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and published guidelines; Arm 2: The treatment will be ART will be a modification where the cavity will be restored with high viscosity glass-ionomer cement (GIC) (GC Fuji Automix LC Resin Reinforced Glass Ionomer Restorative, Japan)). Patients will also receive biannual topical fluoride varnish treatments (FluoriMax, Elevate) according to manufacturer's instructions.

Study Details

Timeline

Interventions