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临床试验/NCT03543163
NCT03543163尚未招募不适用

The Evaluation of Recession Depth After Treating Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft. A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 24 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Recession Depth

研究概览

简要总结

This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II 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
Single (Outcomes Assessor)

盲法说明

  • Blinding of the participants is not applicable.
  • Blinding of the operator is not applicable.
  • Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.

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 are systemically healthy based on questionnaire dental modification of Cornell index.
  • Patients are periodontally healthy with no contraindication for periodontal surgery.
  • All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
  • O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
  • Buccal recession defects are classified as Miller Class I or II.
  • Presence of identifiable CEJ.
  • The papilla fill the interdental spaces as far as the contact area
  • Clinical indication and/or patient request for recession coverage.

排除标准

  • Miller Class III or IV recession defects
  • Pregnant female.
  • Smokers as smoking is contraindicated for any plastic periodontal surgery
  • Patients with special needs or with any mental problems.
  • Patients undergoing radiotherapy
  • Teeth with carious or non-carious lesion or cervical restorations
  • Rotated teeth and tooth extrusion with or without occlusal abrasion
  • Patient undergone any prior periodontal surgery in the relevant region.

研究组 & 干预措施

subepithelial connective tissue graft

Active Comparator

Subepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession.

干预措施: sub-epithelial connective tissue graft (Procedure)

non pedicled buccal fat pad graft

Experimental

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession

干预措施: Non- Pedicled Buccal Fat Pad with Coronally Advanced flap (Procedure)

结局指标

主要结局

Recession Depth

时间窗: 6 months

Measured from the CEJ to the most apical extension of the gingival margin using the UNC-15 periodontal probe and measured in mm unit

次要结局

  • Thickness of keratinized tissue(6 months)
  • Post-operative pain(2 weeks)

研究者

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

Alia Emad Mohammed

associate lecturer

Cairo University

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