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A Modified Tunnel Approach in Treatment of Gingival Recession

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mTA + SCTG
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, tunnel technique, Miller Class I and II

Eligibility Criteria

29 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    The test group

    The control group

    Arm Description

    This group included 30 recession defects treated with mTA + SCTG

    This group included 30 recession defects treated with cTT + SCTG

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The change in percentage of root coverage
    The percentage of root coverage will be calculated at 3 months, then 6 months.
    The change in depth of gingival recession
    The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months.

    Full Information

    First Posted
    December 18, 2015
    Last Updated
    December 26, 2015
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02642887
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    gingival recession, tunnel technique, Miller Class I and II

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The test group
    Arm Type
    Experimental
    Arm Description
    This group included 30 recession defects treated with mTA + SCTG
    Arm Title
    The control group
    Arm Type
    No Intervention
    Arm Description
    This group included 30 recession defects treated with cTT + SCTG
    Intervention Type
    Procedure
    Intervention Name(s)
    mTA + SCTG
    Other Intervention Name(s)
    Dual approach + SCTG
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The change in Root Coverage Esthetic Score
    Description
    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.
    Time Frame
    Baseline, 3 months and 6 months
    Secondary Outcome Measure Information:
    Title
    The change in percentage of root coverage
    Description
    The percentage of root coverage will be calculated at 3 months, then 6 months.
    Time Frame
    Baseline, 3 months and 6 months
    Title
    The change in depth of gingival recession
    Description
    The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months.
    Time Frame
    Baseline, 3 months and 6 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Years
    Maximum Age & Unit of Time
    47 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hala H Hazzaa, Professor
    Organizational Affiliation
    Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24641000
    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.
    Results Reference
    background
    PubMed Identifier
    22639845
    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.
    Results Reference
    background

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    A Modified Tunnel Approach in Treatment of Gingival Recession

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