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The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score

Primary Purpose

Gingival Recession, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
enamel matrix derivatives
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, sub epithelial connective tissue graft, enamel matrix derivatives, root coverage aesthetic score

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • The patient had no systemic disease, did not smoke cigarette and tobacco products, did not have a pregnancy and breastfeeding period, had class I and class II gingival recession according to the Miller gingival classification, had a recession depth of ≥2 mm, have not had a restoration and have had an operation in the relevant dental region that had no previous gingival surgical procedure were included in this study.

Exclusion Criteria:

  • systemic disease
  • multiple gingival recession
  • miller class III and IV recessions were excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SCTG+EMD

    ONLY SCTG

    Arm Description

    TEST GROUP: Langer and Langer technique was used to prepare the recipient side. The vestibule surfaces of adjacent interdental papillae were de-epithelialized. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges. EMD (Emdogain®, Straumann, Basel, Switzerland) was used in the test group in addition to SCTG. Prior to EMD application, the root surface was applied with 24% EDTA (PrefGel, Straumann, Basel, Switzerland) for 2 minutes. The area was washed with saline and then EMD was applied.

    CONTROL GROUP: Langer and Langer technique was used to prepare the recipient side. The anesthetic solution was applied to the donor site in the palatinal region on the same side as the operation site. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges.

    Outcomes

    Primary Outcome Measures

    root coverage percentage
    root coverage percentage of denuded root surface
    root coverage aesthetic score
    root coverage aesthetic score of treatment modalities

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    June 20, 2017
    Sponsor
    Yuzuncu Yıl University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03197610
    Brief Title
    The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score
    Official Title
    The Effect of Enamel Matrix Derivatives on Root Coverage Esthetic Score
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES).
    Detailed Description
    Background: Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic surgical operations is another method in covering denuded root surface. The aim of this study is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete root coverage rate and a newer method root coverage esthetic scoring system (RES). Methods: This is a split-mouth and controlled study. Thirthy-eight Class I or II gingival recession defects at canine teeth were treated in the control (SCTG) (n=19) and test groups (n=19) (SCTG+EMD). The root coverage esthetic score were evaluated by 2 blind periodontists 1 year after the treatment using RES. The agreement between the two periodontists was assessed by kappa analysis. Complete root coverage rate was evaluated for both groups. Two groups were compared with statistically methods in terms of RES parameters and gingival recession height /width.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Periodontal Diseases
    Keywords
    gingival recession, sub epithelial connective tissue graft, enamel matrix derivatives, root coverage aesthetic score

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SCTG+EMD
    Arm Type
    Experimental
    Arm Description
    TEST GROUP: Langer and Langer technique was used to prepare the recipient side. The vestibule surfaces of adjacent interdental papillae were de-epithelialized. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges. EMD (Emdogain®, Straumann, Basel, Switzerland) was used in the test group in addition to SCTG. Prior to EMD application, the root surface was applied with 24% EDTA (PrefGel, Straumann, Basel, Switzerland) for 2 minutes. The area was washed with saline and then EMD was applied.
    Arm Title
    ONLY SCTG
    Arm Type
    Experimental
    Arm Description
    CONTROL GROUP: Langer and Langer technique was used to prepare the recipient side. The anesthetic solution was applied to the donor site in the palatinal region on the same side as the operation site. The dimensions of the recipient area were measured by periodontal probes and four bleeding centers were created in the palatinal region. The graft was placed on the recipient site and fixed with 4.0 silk sutures. Pressure was applied to the operation area for 5 minutes with saline impregnated sponges.
    Intervention Type
    Procedure
    Intervention Name(s)
    enamel matrix derivatives
    Intervention Description
    enamel matrix derivatives and subepithelial connective tissue grafts
    Primary Outcome Measure Information:
    Title
    root coverage percentage
    Description
    root coverage percentage of denuded root surface
    Time Frame
    1 year
    Title
    root coverage aesthetic score
    Description
    root coverage aesthetic score of treatment modalities
    Time Frame
    1 year

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient had no systemic disease, did not smoke cigarette and tobacco products, did not have a pregnancy and breastfeeding period, had class I and class II gingival recession according to the Miller gingival classification, had a recession depth of ≥2 mm, have not had a restoration and have had an operation in the relevant dental region that had no previous gingival surgical procedure were included in this study. Exclusion Criteria: systemic disease multiple gingival recession miller class III and IV recessions were excluded

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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