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Taking people in United StatesEarly phase 1

Adding Arestin to Deep Gum Cleaning in People With Diabetes and Gum Disease

Tests adding Arestin to deep gum cleaning in adults with type 2 diabetes and periodontitis.

Key facts

Who runs it
Case Western Reserve University
Where
Cleveland, United StatesSee the site
Trial code
Registry title
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Status
Recruiting
Phase
Early phase 1
People taking part
42 people, planned
Started
6 Feb 2026
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • local antibiotic application of topical minocycline
  • Scaling and Root Planing
Record updated
19 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and moderate to severe gum disease (periodontitis). It tests deep cleaning with and without Arestin.

Age
18 years or older
Sex
All sexes
Disease stage
Type 2 diabetes with HbA1c from 7.0% (53 mmol/mol) to 9.5% (80 mmol/mol). Moderate to severe periodontitis: pocket depth of 5 mm or more in at least 6 separate sites between teeth, on different teeth.
Earlier treatment
No gum treatment in the last 6 months. No antibiotics in the past 3 months.
Biomarker or test result
HbA1c from 7.0% (53 mmol/mol) to 9.5% (80 mmol/mol)

Main reasons for not taking part

  • Allergy to minocycline or tetracycline
  • Cannot receive or tolerate local anesthesia or ultrasonic tooth instruments
  • Needs IV sedation for the deep cleaning
  • Pregnancy or breastfeeding
  • Smokers, BMI 40 or more, or poorly controlled other diseases

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Allergy to minocycline or tetracycline
  • Smokers or patients with poorly controlled systemic diseases other than diabetes
  • 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+)

Where in United States

  • Case Western Reserve UniversityCleveland, United StatesContact: Gian Pietro Schincaglia, DDS, PhDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Test GroupTreatment being tested

    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.

    Treatment: local antibiotic application of topical minocycline

  • Control GroupExisting treatment, for comparison

    Scaling and Root Planing Alone

    Treatment: Scaling and Root Planing

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Plain-language title
Adding Arestin to Deep Gum Cleaning in People With Diabetes and Gum DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
19 February 2026