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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02642887
Other study ID # Al-Azhar 11-2014
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 18, 2015
Last updated December 26, 2015
Start date March 2015
Est. completion date July 2016

Study information

Verified date December 2015
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 29 Years to 47 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The change in Root Coverage Esthetic Score 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 No
Secondary The change in percentage of root coverage The percentage of root coverage will be calculated at 3 months, then 6 months. Baseline, 3 months and 6 months No
Secondary The change in depth of gingival recession The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months. Baseline, 3 months and 6 months. No
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