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临床试验/NCT03657706
NCT03657706Unknown不适用

Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
试验地点
1
主要终点
root coverage aesthetic score (RES)

研究概览

简要总结

Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.

In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.

详细描述

In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.

Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with healthy systemic condition.
  • Buccal recession defects classified as Miller class III.
  • Clinical indication and/or patient request for recession coverage.
  • O'Leary index less than 20%.

排除标准

  • Pregnant females.
  • Smokers as smoking is a contraindication for any plastic periodontal surgery.
  • Unmotivated, uncooperative patients with poor oral hygiene
  • Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

研究组 & 干预措施

group A

Active Comparator

tunnel procedure with subepithelial connective tissue graft (sCTG)

干预措施: group A (Tunnel procedure with subepithelial connective tissue graft (sCTG) (Procedure)

group B

Active Comparator

tunnel procedure with modified free gingival graft (mFGG)

干预措施: group B (Tunnel procedure with modified free gingival graft (mFGG)) (Procedure)

结局指标

主要结局

root coverage aesthetic score (RES)

时间窗: 6 months

RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables. The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment

次要结局

  • recession depth(6 months)

研究者

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

Nourhan Abdallah Abdelkhalek

Principle investigator

Cairo University

研究点 (1)

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