Overview

This trial is active, not recruiting.

Condition gingival recession
Treatment mta + sctg
Sponsor Al-Azhar University
Start date March 2015
End date January 2016
Trial size 30 participants
Trial identifier NCT02642887, Al-Azhar 11-2014

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
This group included 30 recession defects treated with mTA + SCTG
mta + sctg Dual approach + 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.
(No Intervention)
This group included 30 recession defects treated with cTT + SCTG

Primary Outcomes

Measure
The change in Root Coverage Esthetic Score
time frame: Baseline, 3 months and 6 months

Secondary Outcomes

Measure
The change in percentage of root coverage
time frame: Baseline, 3 months and 6 months
The change in depth of gingival recession
time frame: Baseline, 3 months and 6 months.

Eligibility Criteria

Male or female participants from 29 years up to 47 years old.

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

Additional Information

Official title Evaluation of Root Coverage Outcome Using a Modified Tunnel Approach Versus Tunnel Technique: A Randomized Clinical Trial
Principal investigator Hala H Hazzaa, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Al-Azhar University.