BridgeMD
New treatment option for Periodontitis, Diabetes Mellitus Type 2
Official title Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
ClinicalTrials.gov ID: NCT07298057
What this study is testing
What is local antibiotic application of topical minocycline?
local antibiotic application of topical minocycline is an investigational medicine, being studied as a potential treatment for periodontitis, diabetes mellitus type 2.
Also referred to as Arestin Minocicline microsphere.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.