Menu
Recruiting NCT07298057

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

Early Phase I Interventional Periodontitis, Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: local antibiotic application of topical minocycline, Scaling and Root Planing.
Who it may be relevant to
Registry conditions: Periodontitis, Diabetes Mellitus Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Pocket Closure [Time frame: Baseline, 3 Months, 6 Months]
Secondary outcome measures (2)
  • Changes in Glycemic Control (HbA1c) [Time frame: Baseline, 3 Months, 6 Months]
  • Changes in C-reactive Protein Level (CRP) [Time frame: Baseline, 3 Months, 6 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Case Western Reserve University — Cleveland

Publications

  • Skaleric U, Schara R, Medvescek M, Hanlon A, Doherty F, Lessem J. Periodontal treatment by Arestin and its effects on glycemic control in type 1 diabetes patients. J Int Acad Periodontol. 2004 Oct;6(4 Suppl):160-5. PMID 15536785
  • Simpson TC, Clarkson JE, Worthington HV, MacDonald L, Weldon JC, Needleman I, Iheozor-Ejiofor Z, Wild SH, Qureshi A, Walker A, Patel VA, Boyers D, Twigg J. Treatment of periodontitis for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD004714. doi: 10.1002/14651858.CD004714.pub4. PMID 35420698
  • Preshaw PM, Alba AL, Herrera D, Jepsen S, Konstantinidis A, Makrilakis K, Taylor R. Periodontitis and diabetes: a two-way relationship. Diabetologia. 2012 Jan;55(1):21-31. doi: 10.1007/s00125-011-2342-y. Epub 2011 Nov 6. PMID 22057194

Identifiers

NCT: NCT07298057 · STUDY20250753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗