Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
root coverage[ Time Frame: 9 months ] measured in millimeter |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession. | ||
正式标题 ICMJE | Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial | ||
简要概况 | patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results. Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG. |
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详细说明 | - Population (P): Patients with single Miller class I, II gingival recessions. - Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF). - Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG). - Primary Outcome (O): Root coverage (mm). - Time frame: 9 months. - Study design: Randomized controlled clinical trial. - Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
20 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 2019 | ||
预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Systemically healthy patients 18 years old and older both males and females. - Good oral hygiene after phase I therapy. - Miller's class I or II gingival recession. - Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing. - Cooperative patients able and accept to come for follow up appointments Exclusion Criteria: - Pregnant or lactating females. - Current Smokers. - Patients with any systemic disease that may affect the periodontal healing. - Teeth with endodontic treatment, buccal restoration or caries. - Patients with poor oral hygiene | ||
性别 |
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年龄 | 最小年龄:15 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | heba samir,Cairo University | ||
研究赞助商 ICMJE | Cairo University | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Cairo University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |