Clinical trial NCT02642887: A Modified Tunnel Approach in Treatment of Gingival Recession
Official title: Evaluation of Root Coverage Outcome Using a Modified Tunnel Approach Versus Tunnel Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
tunnel technique
Miller Class I and II
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 29
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in Root Coverage Esthetic Score
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: The change in percentage of root coverage
timeFrame: Baseline, 3 months and 6 months
measure: The change in depth of gingival recession
timeFrame: Baseline, 3 months and 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
name: Hala H Hazzaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
citation: Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.