RightFit
RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with type 2 diabetes and moderate to severe gum disease. It tests whether adding Arestin, an antibiotic, to deep cleaning of the teeth and roots helps close deep gum pockets, control blood sugar, and reduce inflammation in the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older with type 2 diabetes and an HbA1c of 7.0% to 9.5%. HbA1c measures average blood sugar.
  • Moderate to severe gum disease, with gum pockets at least 5 mm deep in at least 6 spots between different teeth.
  • Have at least 16 teeth.
  • Have not had gum disease treatment in the past 6 months.

Who can't join

  • Allergic to minocycline or tetracycline antibiotics.
  • Cannot receive or tolerate medicine that numbs the treatment area.
  • Cannot tolerate tooth cleaning with tools that use sound waves.
  • Need medicine through a vein to relax or sleep during deep cleaning.
  • Have used antibiotics in the past 3 months.
  • Pregnant or breastfeeding.
  • Have a body mass index (BMI) of 40 or higher. BMI is a measure based on height and weight.
  • Smoke or have a poorly controlled disease affecting the body other than diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

OH