A Modified Tunnel Approach in Treatment of Gingival Recession

NCT ID: NCT02642887

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Gingival Recession

Keywords

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gingival recession tunnel technique Miller Class I and II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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The test group

This group included 30 recession defects treated with mTA + SCTG

Group Type EXPERIMENTAL

mTA + SCTG

Intervention Type PROCEDURE

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.

The control group

This group included 30 recession defects treated with cTT + SCTG

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Dual approach + SCTG

Eligibility Criteria

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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
Minimum Eligible Age

29 Years

Maximum Eligible Age

47 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Hala Helmi Hazzaa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala H Hazzaa, Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

References

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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.

Reference Type BACKGROUND
PMID: 24641000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22639845 (View on PubMed)

Other Identifiers

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Al-Azhar 11-2014

Identifier Type: -

Identifier Source: org_study_id