Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Recruiting · NCT07298057 · Interventional (participants receive a specific treatment) · Lead sponsor: Case Western Reserve University
View the official record on ClinicalTrials.gov →Interventions studied
Scaling and Root Planinglocal antibiotic application of topical minocycline
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
1 location listed across 1 US state.
- Case Western Reserve University - Cleveland, Ohio, United States