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Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group A (Lateral closed tunnel subepithelial CT graft)
Group B (Tunnel procedure with subepithelial CT graft)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring tunneling, laterally closed tunnel, gingival recession, recession type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients 18 years or older.
  • Patients with healthy systemic condition
  • Buccal recession defects with recession type 2 defects.
  • Clinical indication and/or patient request for recession coverage.
  • O'Leary index less than 20%

Exclusion Criteria:

  • Pregnant females.
  • Smokers as it is a contraindication for any plastic periodontal surgery
  • Unmotivated, uncooperative patients with poor oral hygiene
  • Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A : Lateral closed Tunnel

    Group B : Tunneling

    Arm Description

    Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. • Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

    Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control: At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together.

    Outcomes

    Primary Outcome Measures

    Percentage complete root coverage
    (Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100

    Secondary Outcome Measures

    Gingival recession depth.
    Measured as the distance between the gingival margin and the mucogingival junction
    Gingival recession width
    Measured as the distance between the gingival margin adjacent to the defect
    Root coverage esthetic score (RES)
    system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
    Probing depth
    Measured from the gingival margin to the bottom of the gingival sulcus
    Clinical attachment level
    Measured from the CEJ to the bottom of the gingival sulcus.
    Width of keratinized tissue
    Measured as the distance between the gingival margin and the mucogingival junction
    Gingival thickness
    The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
    Post-operative pain
    Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)
    Post-Surgical Patient Satisfaction Questionnaire
    A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''

    Full Information

    First Posted
    December 15, 2018
    Last Updated
    January 1, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03791554
    Brief Title
    Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2
    Official Title
    Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 16, 2019 (Anticipated)
    Primary Completion Date
    March 16, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.
    Detailed Description
    Tunneling with subepithelial connective tissue graft: At the recipient site (recession defect): After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. At donor site (palate): A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision. Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture. Tunneling technique with the laterally closed tunnel): After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap. Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site. Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    tunneling, laterally closed tunnel, gingival recession, recession type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Its a randomised clinical trial
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A : Lateral closed Tunnel
    Arm Type
    Active Comparator
    Arm Description
    Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. • Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.
    Arm Title
    Group B : Tunneling
    Arm Type
    Active Comparator
    Arm Description
    Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control: At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together.
    Intervention Type
    Procedure
    Intervention Name(s)
    Group A (Lateral closed tunnel subepithelial CT graft)
    Intervention Description
    Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft
    Intervention Type
    Procedure
    Intervention Name(s)
    Group B (Tunnel procedure with subepithelial CT graft)
    Other Intervention Name(s)
    Autogenous sCTG will be used with tunnel procedure
    Intervention Description
    Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
    Primary Outcome Measure Information:
    Title
    Percentage complete root coverage
    Description
    (Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Gingival recession depth.
    Description
    Measured as the distance between the gingival margin and the mucogingival junction
    Time Frame
    6 month
    Title
    Gingival recession width
    Description
    Measured as the distance between the gingival margin adjacent to the defect
    Time Frame
    6 month
    Title
    Root coverage esthetic score (RES)
    Description
    system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
    Time Frame
    6 month
    Title
    Probing depth
    Description
    Measured from the gingival margin to the bottom of the gingival sulcus
    Time Frame
    6 month
    Title
    Clinical attachment level
    Description
    Measured from the CEJ to the bottom of the gingival sulcus.
    Time Frame
    6 month
    Title
    Width of keratinized tissue
    Description
    Measured as the distance between the gingival margin and the mucogingival junction
    Time Frame
    6 month
    Title
    Gingival thickness
    Description
    The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
    Time Frame
    6 month
    Title
    Post-operative pain
    Description
    Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)
    Time Frame
    2 weeks
    Title
    Post-Surgical Patient Satisfaction Questionnaire
    Description
    A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years or older. Patients with healthy systemic condition Buccal recession defects with recession type 2 defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% Exclusion Criteria: Pregnant females. Smokers as it is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yahya Amer, MSc
    Phone
    +201006194329
    Email
    yahyaamer@live.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manal Hosny, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hani El-Nahass, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    I will check with my Study Chair
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    Citation
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