The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
研究概览
简要总结
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
- •The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
- •All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession
- •All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
- •All patients at least 18 years of age and of both genders.
排除标准
- •Smoker Patients .
- •Patients with diabetes.
- •Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- •pregnant or nursing women.
- •Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
- •Patients with a disease affecting connective tissue metabolism.
- •Patients allergic to collagen.
结局指标
主要结局
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
时间窗: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
次要结局
- Improvement in Gingival Thickness (GT)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Reduction in the Recession Width (RW)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Reduction in Probing Pocket Depth (PPD)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Reduction Clinical Attachment Level (CAL)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Improvement in the Keratinized Tissue Height (KTH)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Measuring Plaque-Index (PI)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
- Measuring Bleeding On Probing (BOP)(Between the baseline preoperative measurement and follow-up at 3 months and 6 months)
研究者
Basima Ghaffoori Ali
PHD student
University of Baghdad