Arestin with deep cleaning to improve gums and blood-sugar control in type 2 diabetes
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
This trial will test whether adding Arestin (minocycline microspheres) to deep dental cleaning helps close periodontal pockets and improves blood sugar and inflammation in adults with type 2 diabetes and moderate to severe periodontitis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07298057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with type 2 diabetes (HbA1c between 7.0% and 9.5%), diagnosed moderate-to-severe periodontitis (≥5 mm pockets in at least six distinct interproximal sites on different teeth), at least 16 teeth present, and no periodontal treatment in the past 6 months are ideal candidates.
Not a fit: Patients who smoke, have morbid obesity (BMI ≥40), recent antibiotic use, allergy to minocycline/tetracyclines, pregnancy or breastfeeding, inability to tolerate local anesthesia or ultrasonic instrumentation, or who require IV sedation are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, adding Arestin to SRP could improve periodontal pocket closure and reduce systemic inflammation, which may produce modest improvements in blood-sugar control.
How similar studies have performed: Previous periodontal studies have shown that Arestin can improve pocket depth reduction when added to SRP, but evidence for meaningful improvements in systemic outcomes like glycemic control is limited and mixed in diabetic populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.