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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 is a Phase 2 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 116 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04830969
The ClinicalTrials.gov registry entry for NCT04830969 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Chlorhexidine gluconate oral rinse is the first listed.
NCT04830969 reports 0 study locations.
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.
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