Actively Recruiting
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Led by Case Western Reserve University · Updated on 2026-02-19
42
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
C
Case Western Reserve University
Lead Sponsor
O
OraPharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Periodontitis is a prevalent chronic inflammatory disease that exacerbates systemic inflammation and poses challenges for glycemic control in diabetic patients. While scaling and root planing (SRP) remains the cornerstone of periodontal therapy, adjunctive treatments such as Arestin (minocycline microspheres) have shown promise in enhancing clinical outcomes. This study aims to evaluate the impact of adding Arestin to SRP on periodontal pocket closure, glycemic control, and systemic inflammation in diabetic patients with periodontitis.
CONDITIONS
Official Title
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) with type 2 diabetes mellitus (HbA1c ≥ 7.0% and ≤9.5%)
- Diagnosed with moderate to severe periodontitis (≥5 mm probing pocket depth in at least 6 distinct interproximal sites on different teeth)
- Have at least 16 teeth present
- No periodontal treatment in the last 6 months
You will not qualify if you...
- Allergy to minocycline or tetracycline
- Unable to receive or tolerate local anesthesia
- Unable to tolerate tooth instrumentation with ultrasonic instruments
- Require IV sedation to receive scaling and root planing
- Use of antibiotics within the past 3 months
- Pregnancy or breastfeeding
- Morbid obesity (BMI 40+)
- Smokers or patients with poorly controlled systemic diseases other than diabetes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
G
Gian Pietro Schincaglia, DDS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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