A Modified Tunnel Approach in Treatment of Gingival Recession

December 26, 2015 updated by: Hala Helmi Hazzaa, Al-Azhar University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The test group
This group included 30 recession defects treated with mTA + SCTG
Procedure: mTA + SCTG
These recession defects will be covered by modified tunnel approach; using a full thickness flap till the level of mucogingival junction then, partial thickness flap will be applied in the vestibular mucosa. SCTG will be harvested from the palate, put on the root surface then covered by the mTA and sutured.
Other Names:
  • Dual approach + SCTG
No Intervention: The control group
This group included 30 recession defects treated with cTT + SCTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in percentage of root coverage
Time Frame: Baseline, 3 months and 6 months
The percentage of root coverage will be calculated at 3 months, then 6 months.
Baseline, 3 months and 6 months
The change in depth of gingival recession
Time Frame: Baseline, 3 months and 6 months.
The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months.
Baseline, 3 months and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Hala H Hazzaa, Professor, Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 26, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 26, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al-Azhar 11-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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