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Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
amnion chorion allograft membrane
coronally advanced flap 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

20 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects aged between 18 - 60 years old.
  • Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
  • Subjects able to tolerate surgical periodontal procedures.
  • Accepts the 6 months follow-up period.

Exclusion Criteria:

  • Current and former smokers.
  • Pregnant females.
  • Subjects received any periodontal therapy for a 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, cervical caries and malalignment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    coronally advanced flap with amnion chorion membrane

    subepithelial connective tissue graft

    Arm Description

    coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.

    coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.

    Outcomes

    Primary Outcome Measures

    recession depth
    It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.

    Secondary Outcome Measures

    Recession Width
    It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
    Width of keratinized gingiva
    It is measured from the mucogingival junction to the free gingival margin.
    Probing pocket depth
    It is measuring the distance from the base of pocket to the gingival margin.
    Clinical attachment level
    It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
    Tissue Biotype
    It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues
    root coverage esthetic score
    The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color
    Patient reported outcomes
    Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure.

    Full Information

    First Posted
    January 13, 2016
    Last Updated
    April 21, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02656732
    Brief Title
    Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
    Official Title
    Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).
    Detailed Description
    The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

    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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    coronally advanced flap with amnion chorion membrane
    Arm Type
    Experimental
    Arm Description
    coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.
    Arm Title
    subepithelial connective tissue graft
    Arm Type
    Active Comparator
    Arm Description
    coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
    Intervention Type
    Biological
    Intervention Name(s)
    amnion chorion allograft membrane
    Other Intervention Name(s)
    BioXclude™,Snoasis Medical products, USA.
    Intervention Description
    Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap with the subepithelial connective tissue graft
    Other Intervention Name(s)
    autogenous connective tissue graft
    Intervention Description
    coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
    Primary Outcome Measure Information:
    Title
    recession depth
    Description
    It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Secondary Outcome Measure Information:
    Title
    Recession Width
    Description
    It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Title
    Width of keratinized gingiva
    Description
    It is measured from the mucogingival junction to the free gingival margin.
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Title
    Probing pocket depth
    Description
    It is measuring the distance from the base of pocket to the gingival margin.
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Title
    Clinical attachment level
    Description
    It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Title
    Tissue Biotype
    Description
    It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues
    Time Frame
    Change in mm from baseline before surgical procedure to follow up at 6 months.
    Title
    root coverage esthetic score
    Description
    The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color
    Time Frame
    score taken after completion of the study at 6 months
    Title
    Patient reported outcomes
    Description
    Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure.
    Time Frame
    taken after completion of the study at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    54 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects aged between 18 - 60 years old. Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification. Subjects able to tolerate surgical periodontal procedures. Accepts the 6 months follow-up period. Exclusion Criteria: Current and former smokers. Pregnant females. Subjects received any periodontal therapy for a 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, cervical caries and malalignment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mona Shoeib, MD
    Organizational Affiliation
    Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hani El-Nahas, MD
    Organizational Affiliation
    Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Manar El-Zanaty, Msc.
    Organizational Affiliation
    manarzanaty@hotmail.com
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    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
    result
    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
    result
    PubMed Identifier
    25644302
    Citation
    Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
    Results Reference
    result
    PubMed Identifier
    26501023
    Citation
    Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1.
    Results Reference
    result
    PubMed Identifier
    17309597
    Citation
    de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
    Results Reference
    result
    PubMed Identifier
    24364174
    Citation
    Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12.
    Results Reference
    result

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    Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

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