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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 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 568 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03916926
The ClinicalTrials.gov registry entry for NCT03916926 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 568 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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