N/A N=568 Randomized Single-blind Treatment

Older Adult Effectiveness of 2 Treatments

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT03916926 ↗

Enrolled (actual)

568

Serious AEs

3.9%

Results posted

Aug 2025

Primary outcome: Primary: Caries Arrest Rate — 0.75; 0.91 surfaces

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: A "simple medical strategy" consisting of silver diamine fluoride (SDF) (Device); B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV) (Device)
Age: Adult, Older Adult · 62+ yrs
Sex: All
Sponsor: Case Western Reserve University
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Caries Arrest Rate	0.88; 0.92	—
PRIMARY Caries Arrest Rate	0.88; 0.92	—
PRIMARY Tooth Pain	0.21; 0.25	—
PRIMARY Tooth Pain	0.21; 0.25	—
SECONDARY Prevention of New Decay	0.67; 0.66	—
SECONDARY Prevention of New Decay	0.67; 0.66	—
SECONDARY Oral Health Related Quality of Life	30.44; 30.04	—
SECONDARY Oral Health Related Quality of Life	30.44; 30.04	—

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.

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

View full record on ClinicalTrials.gov →

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.