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Older Adult Effectiveness of 2 Treatments

NCT03916926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2025-08-13

Study results available
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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.

Conditions

  • Dental Caries

Interventions

DEVICE

A "simple medical strategy" consisting of silver diamine fluoride (SDF)

Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)

DEVICE

B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV)

GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Suchitra S Nelson, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2024-06-07
Completion
2024-06-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916926 on ClinicalTrials.gov