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NCT03762915 · ClinicalTrials.gov registry record · Phase 4
Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
A Phase 4 study of Biomarkers and SRP, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT03762915: Completed Phase 4 study of Biomarkers and SRP, sponsored by University of Minnesota.
NCT03762915 is a Phase 4 study of Biomarkers and SRP that has completed, run by University of Minnesota. The registered enrollment target is 70 participants, below the 738-participant average among 5 other Biomarkers trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762915, a Phase 4 study of Biomarkers and SRP, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load. A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned. Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period. Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.
Primary Outcome
This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions. For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).
Conditions Studied
Interventions
- DRUG minocycline HCl microspheres
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2022-04-01 |
| Phase | Phase 4 |
What the finished NCT03762915 record still lists
NCT03762915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 738-participant average among 5 other Biomarkers trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Biomarkers appearing as the primary indexed condition, and to 1 intervention - of which minocycline HCl microspheres is the first listed.
NCT03762915 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03762915 about?
NCT03762915 is a clinical study titled "Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg". The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load. A randomized controlled clinical trial of a control (SRP) group and an...
What is the current status of trial NCT03762915?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2019-05-20. Estimated completion is 2022-04-01.
What conditions does trial NCT03762915 study?
This clinical trial studies the following conditions: Biomarkers, SRP, Minocycline HCl Microspheres.
What interventions are being tested in trial NCT03762915?
The interventions under investigation include: minocycline HCl microspheres (DRUG).
Who is sponsoring clinical trial NCT03762915?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03762915 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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