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临床试验/NCT02642887
NCT02642887Unknown不适用

Evaluation of Root Coverage Outcome Using a Modified Tunnel Approach Versus Tunnel Technique: A Randomized Clinical Trial

Al-Azhar University0 个研究点目标入组 30 人开始时间: 2015年3月1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
30
主要终点
The change in Root Coverage Esthetic Score

研究概览

简要总结

Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).

Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months postoperatively. The primary outcome was root coverage esthetic scores (RES).

详细描述

Various techniques have been suggested for the treatment of isolated mandibular recessions e.g., envelope, coronally advanced flaps double pedicle flap or tunneling procedures combined with laterally positioned pedicle flaps in conjunction with SCTG. Despite the fact that the mentioned techniques appear to improve root coverage, the success in terms of complete root coverage has high variability and thus it is still unknown which approach may lead to the most predictable outcomes. The limited evidence from the literature points clearly to the clinical importance of developing new concepts for predictable of isolated mandibular recessions.

The MTA is a dual flap approach; that starts with full thickness flap (avoiding papilla incision) till the level of the mucogingival junction. On reaching the level of the vestibular mucosa, a partial thickness flap is applied to undermine the base of the flap. Using this dual approach carries two main advantages: avoidance of severing the gingival blood supply through the full thickness flap, in addition to minimizing the tension on the flap tissue through using the partial thickness flap at the above-mentioned site.

In this trial, the mTA has been proposed for the surgical treatment of isolated mandibular recessions due to the following advantages: 1) it avoids vertical releasing incisions. 2) it doesn't incise the papilla, which may improve the vascularization of the area plus stabilizing the soft tissue flap. 3) it is suitable to patients with thin gingival biotype.

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 (Investigator)

入排标准

年龄范围
29 Years 至 47 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •except for chronic periodontitis, our patients were systemically free
  • •Two mandibular Miller Class I or II recession sites
  • •at least 2 mm attached gingiva.
  • •at least 3 mm depth of recession.

排除标准

  • •Systemic diseases.
  • •Smokers or formal smokers
  • •Pregnant or lactating females
  • •History of antibiotic therapy at the last 6 months
  • •Patients who are not willing to follow the study protocol

研究组 & 干预措施

The test group

Experimental

This group included 30 recession defects treated with mTA + SCTG

干预措施: mTA + SCTG (Procedure)

The control group

No Intervention

This group included 30 recession defects treated with cTT + SCTG

结局指标

主要结局

The change in Root Coverage Esthetic Score

时间窗: Baseline, 3 months and 6 months

This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. It is calculated by expert operator.

次要结局

  • The change in depth of gingival recession(Baseline, 3 months and 6 months.)
  • The change in percentage of root coverage(Baseline, 3 months and 6 months)

研究者

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

Hala Helmi Hazzaa

Assistant Professor

Al-Azhar University

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