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Recruiting Early Phase 1

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

About this study

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.

Condition
Periodontitis, Diabetes Mellitus Type 2
Tested
local antibiotic application of topical minocycline, Scaling and Root Planing
Sponsor
Case Western Reserve University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Periodontitis, Diabetes Mellitus Type 2
  • 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 8

  • 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

Where

1 site, 1 recruiting

Case Western Reserve University

Cleveland, Ohio, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.