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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pocket Closure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Test Group
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.
干预措施: local antibiotic application of topical minocycline (Drug)
Control Group
Scaling and Root Planing Alone
干预措施: Scaling and Root Planing (Procedure)
结局指标
主要结局
Pocket Closure
时间窗: Baseline, 3 Months, 6 Months
Pocket Depth (PD ≤4 mm)
次要结局
- Changes in Glycemic Control (HbA1c)(Baseline, 3 Months, 6 Months)
- Changes in C-reactive Protein Level (CRP)(Baseline, 3 Months, 6 Months)