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NCT Number: NCT07298057

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

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.

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Key information

Conditions

Periodontitis, Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases cyclopia sequence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Gian Pietro Schincaglia, DDS, PhD

CONTACT

[email protected]

216-368-4412

Gian Pietro Schincaglia, DDS, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local antibiotic application of topical minocycline

Drug

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

Other names: Arestin Minocicline microsphere

Scaling and Root Planing

Procedure

Only scaling and root planing

Primary outcomes

  1. Pocket Closure

    Time frame: Baseline, 3 Months, 6 Months

    Pocket Depth (PD ≤4 mm)

Secondary outcomes

  1. Changes in Glycemic Control (HbA1c)

    Time frame: Baseline, 3 Months, 6 Months

    Changes in Blood Sugar Level

  2. Changes in C-reactive Protein Level (CRP)

    Time frame: Baseline, 3 Months, 6 Months

    Changes in Systemic Inflammation

Study contacts

Contact information is provided by the study sponsor or research team.

Gian Pietro Schincaglia, DDS, PhD

CONTACT

[email protected]

216-368-4412

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • OraPharma

Registry information

Official study title

Effectiveness of Scaling and Root Planing With and Without Minocycline Microspheres (Arestin) in Improving Periodontal and Glycemic Outcomes in Diabetic Patients With Periodontitis: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 22, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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