跳至主要内容
临床试验/NCT03340987
NCT03340987Unknown不适用

Clinical Evaluation of the Amount of Root Coverage Following The Use of VISTA Technique Versus Coronally Advanced Flap in Combination With Subepithelial Connective Tissue Graft for Management of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 26 人开始时间: 2018年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
主要终点
Amount of root coverage

研究概览

简要总结

Patients with multiple recession defects will be randomly oriented into to groups. The test group will recieve a relatively new technique, the VISTA technique, combined with connective tissue graft that will be harvested from the palate. The control group will recieve coronally advanced flap with connective tissue graft. subjects will be followed up for 6 months after the surgery. Any complications, that may occur, will be dealt with.

详细描述

The aim of the study is to evaluate the effectiveness of the VISTA technique with subepithelial connective tissue graft for management of multiple gingival recessions compared to the coronally advanced flap with subepithelial connective tissue graft.

• Research hypothesis: Null hypothesis: There is no difference in the amount of root coveragefollowing VISTA technique when comparingVISTA technique versus coronally advanced flap combined with subepithelial connective tissue graft.

Trial design:

  • Blinded, Randomized controlled trial
  • 2 arms:
  1. Intervention:

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with two or more adjacent teeth with Miller class I or II facial gingival recessions.
  • Good oral hygiene
  • Accepts follow-up period (cooperative patients).
  • Patient provides a signed informed consent.

排除标准

  • Patients with systemic disease that may affect periodontal health and healing.
  • Current and former smokers
  • Pregnant females.
  • Subjects received any surgical periodontal therapy in the area of interest for minimum of 6 months prior to the study.
  • Subjects taking drugs known to interfere with wound healing.

研究组 & 干预措施

Vista technique with SCTG

Experimental

vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft

干预措施: vestibular incision subperiosteal tunnel access (Procedure)

coronally advanced flap with SCTG

Active Comparator

coronally advanced flap combined with subepithelial connective tissue graft

干预措施: Coronally advanced flap (Procedure)

结局指标

主要结局

Amount of root coverage

时间窗: 6 months

complete root coverage after surgical correction measured in millimeters by using periodontal probe

次要结局

  • Clinical Attachment level gain in millimeters(6 months)
  • Post-Operative Pain a numerical rating scale(2 weeks)
  • Post-Surgical Patient Satisfaction numerical rating scale(6 months)
  • Root Coverage Esthetic score a numbering score(6 months)
  • Gingival thickness in millimeters(6 months)
  • Post-Operative Swelling verbal rating scale(7 days)
  • Width of Keratinized tissue in millimeters(6 months)
  • Probing depth in millimeters(6 months)

研究者

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

Walaa Shaaban

B.Sc. in Oral and Dental Medicine

Cairo University

相似试验

Clinical Evaluation of the Amount of Root Coverage... | 临床试验