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Comparison of Root Coverage of Gingival Recessions

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
collagen matrix
connective tissue graft
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft, transplantation, collagen, autologous, gingiva

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
  • Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
  • The teeth with gingival recession should not be restored in their cervical portion;
  • Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
  • Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.

Exclusion Criteria:

  • Orthodontic appliances;
  • Fixed or removable prostheses involving the premolar teeth with gingival recession;
  • Being a smoker;
  • Pregnancy or lactation;
  • Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test: collagen matrix

    Control: connective tissue graft

    Arm Description

    Root coverage using collagen matrix

    Root coverage using connective tissue graft

    Outcomes

    Primary Outcome Measures

    gingival recession
    gingival recession
    gingival recession
    gingival recession
    gingival recession
    gingival recession

    Secondary Outcome Measures

    Width of keratinized mucosa

    Full Information

    First Posted
    November 28, 2016
    Last Updated
    November 29, 2016
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02980055
    Brief Title
    Comparison of Root Coverage of Gingival Recessions
    Official Title
    Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    February 2018 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.
    Detailed Description
    A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated. Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy. Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession. After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    connective tissue graft, transplantation, collagen, autologous, gingiva

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test: collagen matrix
    Arm Type
    Experimental
    Arm Description
    Root coverage using collagen matrix
    Arm Title
    Control: connective tissue graft
    Arm Type
    Active Comparator
    Arm Description
    Root coverage using connective tissue graft
    Intervention Type
    Procedure
    Intervention Name(s)
    collagen matrix
    Other Intervention Name(s)
    xenogeneic collagen matrix
    Intervention Description
    Surgical procedure for root coverage using collagen matrix
    Intervention Type
    Procedure
    Intervention Name(s)
    connective tissue graft
    Other Intervention Name(s)
    autologous
    Intervention Description
    Surgical procedure for root coverage using connective tissue graft
    Primary Outcome Measure Information:
    Title
    gingival recession
    Time Frame
    baseline
    Title
    gingival recession
    Time Frame
    three months
    Title
    gingival recession
    Time Frame
    six months
    Title
    gingival recession
    Time Frame
    twelve months
    Title
    gingival recession
    Time Frame
    eighteen months
    Title
    gingival recession
    Time Frame
    twenty-four months
    Secondary Outcome Measure Information:
    Title
    Width of keratinized mucosa
    Time Frame
    baseline and three, six, twelve, eighteen and twenty-four months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines; Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003); The teeth with gingival recession should not be restored in their cervical portion; Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm; Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%. Exclusion Criteria: Orthodontic appliances; Fixed or removable prostheses involving the premolar teeth with gingival recession; Being a smoker; Pregnancy or lactation; Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruno CV Gurgel, Doctor
    Phone
    +558432154107
    Email
    bcgurgel@yahoo.com.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samuel B Borges, student
    Email
    sborges1990@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karyna M Menezes, Master
    Organizational Affiliation
    Universidade Federal do Rio Grande do Norte
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Root Coverage of Gingival Recessions

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