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Placental Membrane for Root Coverage

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
recession coverage
recession coverage and membrane
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, Zuchellis technique,, placental membrane

Eligibility Criteria

23 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients within the age group 23 to 55 years
  2. Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region.
  3. Presence of identifiable cemento-enamel junction
  4. Presence of keratinized tissue apical to the exposed root

Exclusion Criteria:

  1. Systemic complications
  2. Occlusal interferences
  3. Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
  4. Previous periodontal surgery on the involved site
  5. Smokers
  6. Pregnant and lactating mothers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    recession coverage

    recession coverage and membrane

    Arm Description

    30 recession defects treated with Zucchelli's technique.

    30 recession defects treated with Zucchelli's technique along with placental membrane.

    Outcomes

    Primary Outcome Measures

    Height of Gingival recession
    The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe

    Secondary Outcome Measures

    Clinical attachment level
    Clinical attachment level is measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket using williams periodontal probe
    Width of Keratinized Gingiva
    It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe

    Full Information

    First Posted
    February 6, 2017
    Last Updated
    February 12, 2017
    Sponsor
    Meenakshi Ammal Dental College and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03053921
    Brief Title
    Placental Membrane for Root Coverage
    Official Title
    Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 19, 2015 (Actual)
    Primary Completion Date
    March 23, 2016 (Actual)
    Study Completion Date
    June 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meenakshi Ammal Dental College and Hospital

    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
    Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects.
    Detailed Description
    STUDY DESIGN A total number of 60 teeth in 15 subjects were selected. Patients with bilateral Miller's class I and II gingival recession defects in the maxillary or mandibular anterior and premolar region were selected and divided into two groups using a split mouth design. GroupI (Control) -30 recession defects treated with coronally advanced flap alone, using Zucchelli's technique. Group II (Test) - 30 recession defects treated with coronally advanced flap, using Zucchelli's technique along with placental membrane. . CLINICAL PARAMETERS: Probing Pocket Depth(PPD) Clinical Attachment Level(CAL) Height of Gingival Recession(HGR) Width of Gingival Recession(WGR) Width of Keratinized Gingiva(WKG) The clinical parameters were assessed & recorded on 0 day, 90th day and 180th day

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    gingival recession, Zuchellis technique,, placental membrane

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    recession coverage
    Arm Type
    Placebo Comparator
    Arm Description
    30 recession defects treated with Zucchelli's technique.
    Arm Title
    recession coverage and membrane
    Arm Type
    Active Comparator
    Arm Description
    30 recession defects treated with Zucchelli's technique along with placental membrane.
    Intervention Type
    Procedure
    Intervention Name(s)
    recession coverage
    Other Intervention Name(s)
    root coverage technique
    Intervention Description
    recession coverage done using Zuchellis technique
    Intervention Type
    Procedure
    Intervention Name(s)
    recession coverage and membrane
    Other Intervention Name(s)
    root coverage technique with membrane
    Intervention Description
    recession coverage done using Zuchellis technique with placental membrane
    Primary Outcome Measure Information:
    Title
    Height of Gingival recession
    Description
    The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level
    Description
    Clinical attachment level is measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket using williams periodontal probe
    Time Frame
    Baseline and 6 months
    Title
    Width of Keratinized Gingiva
    Description
    It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
    Time Frame
    Baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients within the age group 23 to 55 years Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region. Presence of identifiable cemento-enamel junction Presence of keratinized tissue apical to the exposed root Exclusion Criteria: Systemic complications Occlusal interferences Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing Previous periodontal surgery on the involved site Smokers Pregnant and lactating mothers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah George, BDS
    Organizational Affiliation
    Meenakshi Ammal Dental College and Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19563288
    Citation
    Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
    Results Reference
    background
    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
    background

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    Placental Membrane for Root Coverage

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