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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: Completed Phase 3 study, sponsored by Stony Brook University.
NCT00997178 is a Phase 3 study that has completed, run by Stony Brook University. The registered enrollment target is 514 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00997178 record still lists
NCT00997178 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Non-surgical periodontal therapy is the first listed.
NCT00997178 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00997178's enrollment target sits among peer trials
514 724th of 2000 higher than 1,274 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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