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Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

Primary Purpose

Gingival Recession

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Microsurgery technique for root coverage
Microsurgery technique for root coverage associated to EMD
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

29 Years - 53 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Bilateral gingival recessions in homologous teeth

Exclusion Criteria:

  • Smokers;
  • Systemic diseases;
  • Drugs affecting periodontal health/healing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Enamel Matrix Derivative

    Placebo

    Arm Description

    Microsurgery for root coverage associated with Enamel Matrix Derivative

    Microsurgery for root coverage associated with a Placebo comparator

    Outcomes

    Primary Outcome Measures

    Post-surgical pain
    Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
    Root Coverage Score
    A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)
    Post-surgical Clinical Analysis
    Analysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.
    Changes in Gingival Fluid Biomarkers
    Analysis for IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF by Luminex

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2017
    Last Updated
    February 16, 2017
    Sponsor
    Rio de Janeiro State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03059966
    Brief Title
    Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®
    Official Title
    Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rio de Janeiro State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was the evaluation of inflammatory and healing profile after root coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root coverage surgery with subepithelial connective tissue graft, with and without enamel matrix derivative. The patient screening was based in the following inclusion criteria: bilateral recessions in maxillary anterior homologous teeth with aesthetical complaining ou hypersensitivity, non-smokers, healthy and no use of any medication that compromises periodontal health or healing. The split-mouth randomized model was followed in relation to test and control sites. The following clinical parameters were analyzed at baseline and 6-month post-surgery: recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness. In addition to the surgical analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These evaluations were performed at baseline, 7 and 14 days after surgery.

    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
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enamel Matrix Derivative
    Arm Type
    Experimental
    Arm Description
    Microsurgery for root coverage associated with Enamel Matrix Derivative
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Microsurgery for root coverage associated with a Placebo comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Microsurgery technique for root coverage
    Intervention Description
    Microsurgery technique for root coverage adapted for macrosurgery
    Intervention Type
    Biological
    Intervention Name(s)
    Microsurgery technique for root coverage associated to EMD
    Intervention Description
    Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative
    Primary Outcome Measure Information:
    Title
    Post-surgical pain
    Description
    Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
    Time Frame
    7 days after surgery
    Title
    Root Coverage Score
    Description
    A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)
    Time Frame
    180 days after surgery
    Title
    Post-surgical Clinical Analysis
    Description
    Analysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.
    Time Frame
    180 days after surgery
    Title
    Changes in Gingival Fluid Biomarkers
    Description
    Analysis for IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF by Luminex
    Time Frame
    Baseline, 7 and 14 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Years
    Maximum Age & Unit of Time
    53 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Bilateral gingival recessions in homologous teeth Exclusion Criteria: Smokers; Systemic diseases; Drugs affecting periodontal health/healing.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

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