Clinical Effectiveness of a Topical Subgingival Application of Injectable Platelet-rich Fibrin as Adjunctive Therapy to Scaling and Root Planing. A Double-blind Split Mouth Randomized Prospective Comparative Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Probing pocket depth (PD)
研究概览
简要总结
Clinical evaluation of local administration of injectable PRF (injectable platelet-rich fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15 periodontal patients will receive a through traditional mechanical treatment (scaling and root planing). Each patient will receive subgingival i-PRF injected in half mouth and the opposite side will be injected with saline, immediately after the deep scaling session.
详细描述
The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design. The injected half mouth (study group) for each patient will be allocated randomly. The opposite side will be injected with saline (control group). Clinical parameters will be evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are in general good health.
- •Patients are from both gender and are adult.
- •A sign informed consent from participation and permission to use obtained data for research purposes.
- •They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
- •Presence of bilateral periodontal pockets (≥5 mm) on the minimum of 2 teeth in each side.
排除标准
- •Patients less than 18 years' old
- •Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…)
- •clotting and Hematological disorders
- •Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use
- •The teeth with poor bad filling and poorly fitted restorations
结局指标
主要结局
Probing pocket depth (PD)
时间窗: baseline, 2 months
measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
Clinical attachment level (CAL)
时间窗: baseline, 2 months
measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
次要结局
- full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)(baseline, 2 months)
- Modified Gingival Index (Trombelli et al. 2004)(baseline, 2 months)
- Bleeding on probing (BOP)(baseline, 2 months)
研究者
Hala Albonni
Dr.
Syrian Private University