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临床试验/NCT04133298
NCT04133298已完成不适用

Evaluation of Tunneling Technique With Subepithelial Connective Tissue Graft Vs. Laser De-epithelialized Gingival Graft in Management of Multiple Cairo RT-2 Gingival Recessions.

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年3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
22
试验地点
1
主要终点
Gingival Thickness gain

研究概览

简要总结

This study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. half pf participants will be treated from gingival recession using tunneling technique with laser de-epithelized gingival graft, while the other half will be treated using tunneling technique with subepithelial connective tissue graft.

详细描述

Tunneling technique is a minimal invasive method for coronal advancement during gingival recession coverage. The technique provide better blood supply which enhances wound healing and results in successful root coverage and attachment gain. Tunneling technique is suggested to be incorporated with a soft tissue tissue for better recipient site outcome.

In a systemic review and meta-analysis conducted in 2019 there was limited evidence available comparing subepithelial connective tissue graft to the de-epithelialized gingival graft. However the de-epithelialized gingival graft showed superior mean root coverage, keratinized tissue gain and clinical attachment gain over the subepithelial connective tissue graft making it the technique of choice when incorporated with coronal advancement flap in treatment of gingival recession. Laser de-epithelization may enrich the advantages of the conventional de-epithelization method where more uniform predictable epithelization can be obtained.

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.
  • The outcome assessor and biostatistician will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Anterior teeth and premolars with multiple Miller's Class I and II gingival recessions.
  • Identifiable cemento-enamel junction.
  • The teeth with gingival recessions are vital teeth.
  • Plaque Index and Gingival bleeding index less than 20% after phase one therapy.

排除标准

  • Patients with systemic diseases and medical conditions that may affect the treatment outcomes.
  • Prosthetic crown, restoration or tooth decay involving the CEJ.
  • Previous periodontal surgery in the area of interest.

结局指标

主要结局

Gingival Thickness gain

时间窗: 6 month

it will be calculated based on volumetric difference of a defined area located on attached gingiva above the site to be corrected surgically, that is by taking a base line digital impression and superimpose it to another digital impression 6 month postoperatively. Buccal tooth surface will be used as a reference for the superimposition procedure. The digital measurements will be taken to nearest 0.01mm. Finally, gingival thickness gain will be calculated as the measured volume gain per measured area, \[Gingival thickness gain (mm) = volume (mm3) / area (mm2)\].

次要结局

  • root coverage gain(6 month)
  • Clinical attachment level gain(6 month)
  • Post-operative pain score(2 weeks)
  • Patient satisfaction(2 weeks)
  • Keratinized tissue width gain(6 month)
  • Probing depth(6 month)

研究者

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

Mohamed Gamal

Principal Investigator

Cairo University

研究点 (1)

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