N/A
Completed N=568
Older Adult Effectiveness of 2 Treatments
Source: ClinicalTrials.gov NCT03916926 ↗Enrolled (actual)
568
Serious AEs
3.9%
Results posted
Aug 2025
Primary outcomePrimary: Caries Arrest Rate — 0.75; 0.91 surfaces
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caries Arrest Rate |
0.88; 0.92 | — |
| PRIMARY Tooth Pain |
0.21; 0.25 | — |
| SECONDARY Prevention of New Decay |
0.67; 0.66 | — |
| SECONDARY Oral Health Related Quality of Life |
30.44; 30.04 | — |
Eligibility Criteria
Inclusion Criteria
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study (1 year)
- Male or female, aged 62 years or older
- Live in a participating older adult housing facility to continue in the clinical trial phase of the study, an individual must:
- Have at least one untreated active root or coronal carious lesion with ICDAS-II (2015) lesion severity code of 3 or greater
Exclusion Criteria
- Sensitivity to silver or other heavy-metal ions
- Those with ulcerative gingivitis or stomatitis
- Serious life-threatening medical disease
Data sourced from ClinicalTrials.gov (NCT03916926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.