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Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acellular Dermal Matrix
Tunnel technique with the subepithelial connective tissue graft
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
  • Subjects aged between 18 - 60 years old.
  • Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
  • Patients with good oral hygiene.

Exclusion Criteria:

  • Current and former smokers.
  • Pregnant females.
  • Subjects received any periodontal therapy for minimum of 6 months prior to the study.
  • Subjects taking drugs known to interfere with wound healing.
  • Subjects with unacceptable oral hygiene with plaque index >2.
  • Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tunnel technique with acellular dermal matrix

    subepithelial connective tissue graft

    Arm Description

    the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface.

    Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap.

    Outcomes

    Primary Outcome Measures

    patient Satisfaction .
    measured by VAS scale

    Secondary Outcome Measures

    root coverage
    measured by periodontal probe
    Clinical Attachment Level
    measured by periodontal probe
    Width of Keratinized Tissue
    measured by periodontal probe
    Gingival Bio-type
    measured by endodontics file

    Full Information

    First Posted
    September 21, 2016
    Last Updated
    September 26, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02916186
    Brief Title
    Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions
    Official Title
    Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.
    Detailed Description
    Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tunnel technique with acellular dermal matrix
    Arm Type
    Experimental
    Arm Description
    the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface.
    Arm Title
    subepithelial connective tissue graft
    Arm Type
    Active Comparator
    Arm Description
    Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap.
    Intervention Type
    Biological
    Intervention Name(s)
    Acellular Dermal Matrix
    Other Intervention Name(s)
    Puros Dermis Allograft Tissue Matrix
    Intervention Description
    Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tunnel technique with the subepithelial connective tissue graft
    Other Intervention Name(s)
    autogenous connective tissue graft
    Intervention Description
    Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate
    Primary Outcome Measure Information:
    Title
    patient Satisfaction .
    Description
    measured by VAS scale
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    root coverage
    Description
    measured by periodontal probe
    Time Frame
    1 year
    Title
    Clinical Attachment Level
    Description
    measured by periodontal probe
    Time Frame
    1 year
    Title
    Width of Keratinized Tissue
    Description
    measured by periodontal probe
    Time Frame
    1 year
    Title
    Gingival Bio-type
    Description
    measured by endodontics file
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985). Subjects aged between 18 - 60 years old. Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome. Patients with good oral hygiene. Exclusion Criteria: Current and former smokers. Pregnant females. Subjects received any periodontal therapy for minimum of 6 months prior to the study. Subjects taking drugs known to interfere with wound healing. Subjects with unacceptable oral hygiene with plaque index >2. Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions

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