Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07298057
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Periodontitis, Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • local antibiotic application of topical minocycline — DRUG
    Scaling and Root planing + local application of Arestin ( Minocycline microsphere)
  • Scaling and Root Planing — PROCEDURE
    Only scaling and root planing

Study Details

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.

Key Dates

Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Group
    Minocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.
  • Active Comparator: Control Group
    Scaling and Root Planing Alone

Primary Outcome Measure

Pocket Closure [ Time Frame: Baseline, 3 Months, 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Gian Pietro Schincaglia, DDS, PhD
216-368-4412
Gian Pietro Schincaglia, DDS, PhD (PRINCIPAL_INVESTIGATOR)

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