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

Case Western Reserve University

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Periodontitis, Diabetes Mellitus Type 2

Treatments: Procedure: Scaling and Root Planing; Drug: local antibiotic application of topical minocycline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07298057

STUDY20250753

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Test Group

Experimental group

Description:

Minocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.

Treatment:

Drug: local antibiotic application of topical minocycline

Control Group

Active Comparator group

Description:

Scaling and Root Planing Alone

Treatment:

Procedure: Scaling and Root Planing