Periodontitis, Diabetes Mellitus Type 2
Conditions
Keywords
Scaling and Root Planing, Arestin, Diabetes Mellitus Type 2
Brief summary
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.
Interventions
DRUGlocal antibiotic application of topical minocycline
Scaling and Root planing + local application of Arestin ( Minocycline microsphere)
PROCEDUREScaling and Root Planing
Only scaling and root planing
Sponsors
Case Western Reserve University
OraPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Closure | Baseline, 3 Months, 6 Months | Pocket Depth (PD ≤4 mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glycemic Control (HbA1c) | Baseline, 3 Months, 6 Months | Changes in Blood Sugar Level |
| Changes in C-reactive Protein Level (CRP) | Baseline, 3 Months, 6 Months | Changes in Systemic Inflammation |
Countries
United States
Contacts
CONTACTGian Pietro Schincaglia, DDS, PhD
PRINCIPAL_INVESTIGATORGian Pietro Schincaglia, DDS, PhD
Case Western Reserve University
Outcome results
None listed