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临床试验/NCT03791554
NCT03791554已完成不适用

Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年8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
已完成
入组人数
24
试验地点
1
主要终点
Reduction Recession Depth

研究概览

简要总结

This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

详细描述

Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

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
Double (Participant, 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
是

入选标准

  • •Patients 18 years or older.
  • •Patients with healthy systemic condition
  • •Buccal recession defects with recession type 2 defects.
  • •Clinical indication and/or patient request for recession coverage.
  • •O'Leary index less than 20%

排除标准

  • •Pregnant females.
  • •Smokers as it 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 : Lateral closed Tunnel

Active Comparator

Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

• Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

干预措施: Group A (Lateral closed tunnel subepithelial CT graft) (Procedure)

Group B : Tunneling

Active Comparator

Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control:

At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together.

干预措施: Group B (Tunnel procedure with subepithelial CT graft) (Procedure)

结局指标

主要结局

Reduction Recession Depth

时间窗: 6 month

recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.

次要结局

  • Gingival thickness(6 month)
  • Gingival recession depth.(6 month)
  • Root coverage esthetic score (RES)(6 month)
  • Probing depth(6 month)
  • Width of keratinized tissue(6 month)
  • Post-operative pain(2 weeks)
  • Gingival recession width(6 month)
  • Clinical attachment level(6 month)
  • Percentage complete root coverage(6 month)
  • Post-Surgical Patient Satisfaction Questionnaire(6 month)

研究者

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

Yahya Hassan El Banna Amer

Assistant Lecturer

Cairo University

研究点 (1)

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