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临床试验/CTRI/2018/10/016189
CTRI/2018/10/016189已完成Unknown

Evaluation Of Gingival Recession Defects With Platelet Rich Fibrin Matrix And Collagen Membrane: A Comparative Clinical Study

Angelin Rejoice1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月24日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
•Recession width at cemento-enamel junction.

研究概览

简要总结

The study is an randomized clinical trial, aimed to find the efficacy of platelet rich fibrin matrix and collagen membrane on miller’s class I and class II gingival recession. 20 identical bilateral recession defects will be selected and randomly allocated in to Group A ( collagen membrane) and Group B ( PRFM). The procedure will be explained to the patient and  informed consent is obtained. In the presurgical phase, scaling and re-evaluation carried on follwed by coronally advanced flap and placement of membrane or PRFM  according to the desired site,  followed by placement of periodontal dressing. Post-operative instructions are given, along with prescription of antibiotics, analgesics and chlorhexidine mouth wash. The study duration of two years, the clinical parameters will be recorded at baseline, 3 months and 6 months.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1 Systemically healthy subjects.
  • 2 Age: 18-50 years.
  • 3 Identical bilateral Miller’s class I and II isolated gingival recession.
  • 4 Patients with more than 1mm of width of keratinized gingiva.
  • •Presence of good oral hygiene maintenance.

排除标准

  • 1 History of subjects who underwent previous periodontal surgery for past 6 month.
  • 2 Presence of dehiscence or fenestration.
  • 3 Malposed / rotated teeth/ root caries.
  • 4 Smokers and chewers of tobacco.
  • 5 Pregnant or lactating mother.

结局指标

主要结局

•Recession width at cemento-enamel junction.

时间窗: baseline, 3months, 6 months

•Clinical attachment level.

时间窗: baseline, 3months, 6 months

•Probing depth.

时间窗: baseline, 3months, 6 months

•Recession depth

时间窗: baseline, 3months, 6 months

•Keratinized gingival width.

时间窗: baseline, 3months, 6 months

次要结局

  • Gingival index, Plaque index(Baseline, 3months, 6 months)
  • . Assessment of soft tissue healing(. 1 week, 3 months, 6 months)

研究者

发起方
Angelin Rejoice
申办方类型
Other []

研究点 (1)

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