NCT07298057EARLY_PHASE1Recruiting
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Case Western Reserve University
Start Date
2/6/2026
Completion Date
6/1/2028
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
local antibiotic application of topical minocycline
PROCEDURE
Scaling and Root Planing
Conditions
Periodontitis, Diabetes Mellitus Type 2
Locations
Case Western Reserve University
Cleveland, Ohio 44106
United States