RecruitingEarly Phase 1NCT07298057

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

Effectiveness of Scaling and Root Planing With and Without Minocycline Microspheres (Arestin) in Improving Periodontal and Glycemic Outcomes in Diabetic Patients With Periodontitis: A Randomized Controlled Trial


Sponsor

Case Western Reserve University

Enrollment

42 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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)
  • At least 16 teeth present
  • No periodontal treatment in the last 6 months

Exclusion Criteria8

  • Allergy to minocycline or tetracycline
  • Unable to receive or to 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

Interventions

DRUGlocal antibiotic application of topical minocycline

Scaling and Root planing + local application of Arestin ( Minocycline microsphere)

PROCEDUREScaling and Root Planing

Only scaling and root planing


Locations(1)

Case Western Reserve University

Cleveland, Ohio, United States

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NCT07298057