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Surgical Treatment of Gingival Recessions

Primary Purpose

Clinical Trial, Connective Tissue, Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical techniques in the treatment of localized gingival recession defects.
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-

All participants were:

  • adults aged 18 years or over
  • systemically and periodontally healthy
  • met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

Exclusion Criteria:

-

Exclusion criteria included the following:

  • medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
  • a history of chemotherapy or radiotherapy;
  • a history of alcoholism or drug abuse;
  • a history of previous mucogingival surgery at the gingival recession site;
  • medications known to affect gingival tissues;
  • antibiotic treatment in the past 6 months;
  • smoking >10 cigarettes per day for >5 years, and;
  • current pregnancy or lactation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Microsurgery group

    Macrosurgery group

    Arm Description

    All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.

    All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.

    Outcomes

    Primary Outcome Measures

    Percentage of root coverage
    The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.

    Secondary Outcome Measures

    Changes in Gingival recession depth
    Changes in Gingival recession width
    Changes in Keratinized gingival width
    visual analog scale
    A visual analog scale was used to evaluate postoperative complaints regarding the recipient and donor sites according to graft size and postoperative satisfaction values (level of the gingival margin, gingival tissue color, dentin hypersensitivity, and root coverage) during the follow-up period. A 10 cm VAS, with "none" / "unhappy" at the left end and "unbearable" / "happy" at the right end was prepared for each patient.

    Full Information

    First Posted
    October 12, 2020
    Last Updated
    September 26, 2023
    Sponsor
    Istanbul Medipol University Hospital
    Collaborators
    Kirsehir Ahi Evran University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04611282
    Brief Title
    Surgical Treatment of Gingival Recessions
    Official Title
    Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medipol University Hospital
    Collaborators
    Kirsehir Ahi Evran University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clinical Trial, Connective Tissue, Gingival Recession, Microsurgery

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Microsurgery group
    Arm Type
    Experimental
    Arm Description
    All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.
    Arm Title
    Macrosurgery group
    Arm Type
    Active Comparator
    Arm Description
    All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical techniques in the treatment of localized gingival recession defects.
    Intervention Description
    Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
    Primary Outcome Measure Information:
    Title
    Percentage of root coverage
    Description
    The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Changes in Gingival recession depth
    Time Frame
    6 months
    Title
    Changes in Gingival recession width
    Time Frame
    6 months
    Title
    Changes in Keratinized gingival width
    Time Frame
    6 months
    Title
    visual analog scale
    Description
    A visual analog scale was used to evaluate postoperative complaints regarding the recipient and donor sites according to graft size and postoperative satisfaction values (level of the gingival margin, gingival tissue color, dentin hypersensitivity, and root coverage) during the follow-up period. A 10 cm VAS, with "none" / "unhappy" at the left end and "unbearable" / "happy" at the right end was prepared for each patient.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - All participants were: adults aged 18 years or over systemically and periodontally healthy met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme Exclusion Criteria: - Exclusion criteria included the following: medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis; a history of chemotherapy or radiotherapy; a history of alcoholism or drug abuse; a history of previous mucogingival surgery at the gingival recession site; medications known to affect gingival tissues; antibiotic treatment in the past 6 months; smoking >10 cigarettes per day for >5 years, and; current pregnancy or lactation.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Surgical Treatment of Gingival Recessions

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