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NCT02601833 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
A Phase 3 study of Caries, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 2
- Study locations
NCT02601833: Completed Phase 3 study of Caries, sponsored by University of Michigan.
NCT02601833 is a Phase 3 study of Caries that has completed, run by University of Michigan. The registered enrollment target is 98 participants, above the 46-participant average among 7 other Caries trials with a reported enrollment target (113% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601833, a Phase 3 study of Caries, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.
Primary Outcome
Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.
Conditions Studied
Interventions
- DEVICE Silver Diamine Fluoride
- PROCEDURE Conventional Caries Management
Study Locations (2)
Michigan
- University of Michigan School of Dentistry - Ann Arbor
- Mott Children's Health Center - Flint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2016-01 |
| Est. Completion | 2020-09-18 |
| Phase | Phase 3 |
What the finished NCT02601833 record still lists
NCT02601833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 46-participant average among 7 other Caries trials with a reported enrollment target (113% higher).
The record links to 1 condition, with Caries appearing as the primary indexed condition, and to 2 interventions - of which Silver Diamine Fluoride is the first listed.
NCT02601833 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02601833 about?
NCT02601833 is a clinical study titled "Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques". The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.
What is the current status of trial NCT02601833?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2016-01. Estimated completion is 2020-09-18.
What conditions does trial NCT02601833 study?
This clinical trial studies the following conditions: Caries.
What interventions are being tested in trial NCT02601833?
The interventions under investigation include: Silver Diamine Fluoride (DEVICE), Conventional Caries Management (PROCEDURE).
Who is sponsoring clinical trial NCT02601833?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02601833 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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