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NCT04830969 · ClinicalTrials.gov registry record · Phase 2
Impact of Periodontal Therapy on Patients With Diabetes
A Phase 2 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT04830969: Completed Phase 2 study, sponsored by State University of New York at Buffalo.
NCT04830969 is a Phase 2 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04830969, a Phase 2 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used: 1. Scaling and root planning (SRP) alone, or 2. SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.
Primary Outcome
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Interventions
- DRUG Chlorhexidine gluconate oral rinse
- PROCEDURE Scaling & Root Planing
- DEVICE Soft Picks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2016-11-08 |
| Est. Completion | 2021-01-28 |
| Phase | Phase 2 |
What the finished NCT04830969 record still lists
NCT04830969 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Chlorhexidine gluconate oral rinse is the first listed.
NCT04830969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04830969 about?
NCT04830969 is a clinical study titled "Impact of Periodontal Therapy on Patients With Diabetes". With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial pro...
What is the current status of trial NCT04830969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2016-11-08. Estimated completion is 2021-01-28.
What interventions are being tested in trial NCT04830969?
The interventions under investigation include: Chlorhexidine gluconate oral rinse (DRUG), Scaling & Root Planing (PROCEDURE), Soft Picks (DEVICE).
Who is sponsoring clinical trial NCT04830969?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04830969's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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