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Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics

RECRUITINGEarly 1Sponsored by Case Western Reserve University
Actively Recruiting
PhaseEarly 1
SponsorCase Western Reserve University
Started2026-02-06
Est. completion2027-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Adults (≥18 years) with type 2 diabetes mellitus (HbA1c ≥ 7.0% and ≤9.5%)
2. Diagnosed with moderate to severe periodontitis (≥5 mm probing pocket depth in at least 6 distinct interproximal sites, on different teeth)
3. At least 16 teeth present
4. No periodontal treatment in the last 6 months

Exclusion Criteria:

1. Allergy to minocycline or tetracycline
2. Unable to receive or to tolerate local anesthesia
3. Unable to tolerate tooth instrumentation with ultrasonic instruments.
4. Require IV sedation to receive scaling and root planing
5. Use of antibiotics within the past 3 months
6. Pregnancy or breastfeeding
7. Morbid Obesity (BMI 40+)
8. Smokers or patients with poorly controlled systemic diseases other than diabetes

Conditions2

DiabetesPeriodontitis, Diabetes Mellitus Type 2

Locations1 site

Case Western Reserve University
Cleveland, Ohio, 44106
Gian Pietro Schincaglia, DDS, PhD216-368-4412gxs486@case.edu

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