Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum Haptoglobin Concentration
研究概览
简要总结
The primary goal of this study is to determine the amount of three systemic markers of inflammation: 1) Hemoglobin A1c (Hgb A1c, 2) High Sensitivity C-Reactive Protein (hsCRP), and 3) Haptoglobin (Hp) at 9 and 12 month follow-up post scaling and rootplaning (SRP) with and without minocycline HCl microspheres, 1 mg.
详细描述
Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participated in interventional phase of the trial STUDY00004876
排除标准
- •Unable to comply with study protocol
- •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.)
- •Any medication that may impact periodontal conditions (Phenytoin, calciumantagonists, cyclosporin, warfarin, or NSAIDS)
结局指标
主要结局
Serum Haptoglobin Concentration
时间窗: 12 months
Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration
时间窗: 12 months
Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l.
Serum Hemoglobin A1C Concentration
时间窗: 12 months
Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes).
次要结局
未报告次要终点