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
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
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
NCT ID
NCT02642887
First Posted
December 18, 2015
Last Updated
December 26, 2015
Sponsor
Al-Azhar University
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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