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Clinical Trials/NCT02642887
NCT02642887
Unknown
Not Applicable

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

Al-Azhar University0 sites30 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Al-Azhar University
Enrollment
30
Primary Endpoint
The change in Root Coverage Esthetic Score
Last Updated
10 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
July 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hala Helmi Hazzaa

Assistant Professor

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

The change in Root Coverage Esthetic Score

Time Frame: 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.

Secondary Outcomes

  • 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)

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