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NCT03916926 · ClinicalTrials.gov registry record · NA
Older Adult Effectiveness of 2 Treatments
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 568
- Enrollment target
NCT03916926: Completed NA study, sponsored by Case Western Reserve University.
NCT03916926 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 568 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916926, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 568 participants
- Enrollment target
Study 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.
Primary Outcome
International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S
Interventions
- DEVICE 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2019-09-18 |
| Est. Completion | 2024-06-07 |
| Phase | NA |
What the finished NCT03916926 record still lists
NCT03916926 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which A "simple medical strategy" consisting of silver diamine fluoride (SDF) is the first listed.
NCT03916926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916926 about?
NCT03916926 is a clinical study titled "Older Adult Effectiveness of 2 Treatments". 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) -...
What is the current status of trial NCT03916926?
This trial is currently completed. It is a NA study. The enrollment target is 568 participants. The study started on 2019-09-18. Estimated completion is 2024-06-07.
What interventions are being tested in trial NCT03916926?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03916926?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03916926's enrollment target sits among peer trials
568 180th of 2000 higher than 1,821 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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