Arestin with deep cleaning to improve gums and blood-sugar control in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, single-site trial at Case Western Reserve University will enroll adults with type 2 diabetes (HbA1c 7.0–9.5%) and moderate-to-severe periodontitis to receive scaling and root planing (SRP) with or without topical minocycline microspheres (Arestin). Participants will receive SRP and targeted local application of Arestin into periodontal pockets, with follow-up visits to measure periodontal pocket depth, clinical attachment, HbA1c, and systemic inflammation markers. Key eligibility requirements include at least 16 teeth present, no periodontal treatment in the prior 6 months, no recent antibiotic use, and exclusion of smokers and certain systemic conditions. The trial is designed to see if the adjunctive local antibiotic improves periodontal healing and has downstream effects on glycemic control compared with SRP alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Case Western Reserve University
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Gian Pietro Schincaglia, DDS, PhD — Case Western Reserve University
• Study coordinator: Gian Pietro Schincaglia, DDS, PhD
• Email: gxs486@case.edu
• Phone: 216-368-4412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.