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临床试验/NCT03199118
NCT03199118已完成不适用

The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Recession Depth

研究概览

简要总结

This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.

详细描述

The study population will be divided into 2 groups:

Group 1:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years

Group 2:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.
  • Clinical indication and/or patient request for recession coverage 4) Good oral hygiene

排除标准

  • Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .
  • Teeth with cervical restorations, abrasion

结局指标

主要结局

Recession Depth

时间窗: baseline-3 months-6 months

measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.

次要结局

  • Post Operative Pain(after 2 weeks from surgery)
  • Clinical Attachment Level(baseline-3 months-6 months)
  • Recession Width(baseline-3 months-6 months)
  • Root Coverage Gain(at 6 months)
  • Probing Depth(baseline-3 months-6 months)
  • Patient Satisfaction(questionnaire given to the patient 6 months after the surgery)
  • Root Coverage Esthetic Score (RES)(6 months)
  • Gingival Biotype(baseline-3 months-6 months)
  • Width of Keratinized Gingiva(baseline-3 months-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Elbanna

Assistant lecturer in the oral medicine and periodontology department

Cairo University

研究点 (2)

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