Recruiting
Early Phase 1

SRP with Arestin

Sponsor:

Case Western Reserve University

Code:

NCT07298057

Conditions

Periodontitis, Diabetes Mellitus Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

local antibiotic application of topical minocycline

Scaling and Root Planing

Study Details

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.

Conditions

Periodontitis, Diabetes Mellitus Type 2

Study ID

NCT07298057

Start date

Feb 6, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

local antibiotic application of topical minocycline

Scaling and Root planing + local application of Arestin ( Minocycline microsphere)

Scaling and Root Planing

Only scaling and root planing

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gian Pietro Schincaglia, DDS, PhD

216-368-4412gxs486@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gian Pietro Schincaglia, DDS, PhD

216-368-4412gxs486@case.edu

Principal Investigator:

Gian Pietro Schincaglia, DDS, PhD

More Information

Sponsor

Case Western Reserve University

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Scaling and Root Planing
  • Arestin
  • Diabetes Mellitus Type 2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-02-19.