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NCT00997178 · ClinicalTrials.gov registry record · Phase 3
Diabetes and Periodontal Therapy Trial
A Phase 3 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
NCT00997178 is a Phase 3 study that has completed, run by Stony Brook University. The registered enrollment target is 514 participants.
The verdict
NCT00997178, a Phase 3 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
Study Summary
The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. The secondary aims of the study are to: 1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2). 2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.
Interventions
- PROCEDURE Non-surgical periodontal therapy
- OTHER Delayed non-surgical periodontal therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00997178
The ClinicalTrials.gov registry entry for NCT00997178 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Non-surgical periodontal therapy is the first listed.
NCT00997178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00997178 about?
NCT00997178 is a clinical study titled "Diabetes and Periodontal Therapy Trial". The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabet...
What is the current status of trial NCT00997178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2009-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00997178?
The interventions under investigation include: Non-surgical periodontal therapy (PROCEDURE), Delayed non-surgical periodontal therapy (OTHER).
Who is sponsoring clinical trial NCT00997178?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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