Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- local antibiotic application of topical minocycline
- Scaling and Root Planing
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Case Western Reserve University
Lead sponsor
OraPharma
Collaborator
Source ClinicalTrials.gov