RecruitingRecruiting
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
NCT07298057 · Case Western Reserve University
In plain English
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Official title
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
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.
Eligibility criteria
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
Study design
Enrollment target: 42 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-06
Estimated completion: 2028-06
Last updated: 2026-02-19
Interventions
Drug: local antibiotic application of topical minocyclineProcedure: Scaling and Root Planing
Primary outcomes
- • Pocket Closure (Baseline, 3 Months, 6 Months)
Sponsor
Case Western Reserve University · other
With: OraPharma
Contacts & investigators
ContactGian Pietro Schincaglia, DDS, PhD · contact · gxs486@case.edu · 216-368-4412
InvestigatorGian Pietro Schincaglia, DDS, PhD · principal_investigator, Case Western Reserve University
All locations (1)
Case Western Reserve UniversityRecruiting
Cleveland, Ohio, United States