Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Bacteria Load (log10)
研究概览
简要总结
The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load.
A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.
Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period.
Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.
详细描述
A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.
The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. Saliva samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and TNF-α.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female
- •At least 18 years of age
- •ADA Class III-IV Chronic Periodontitis
- •Scaling and Root Planing (SRP) or localized SRP
- •A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)
排除标准
- •Unable to comply with study protocol
- •Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
- •Cigarette use within the last year
- •≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
- •Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
- •Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
- •Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c > 7, HIV, etc.)
- •Tetracycline allergy
- •Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)
研究组 & 干预措施
SRP with minocycline HCl microspheres
The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.
干预措施: minocycline HCl microspheres (Drug)
结局指标
主要结局
Bacteria Load (log10)
时间窗: 6 months
This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions. For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).
次要结局
未报告次要终点