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Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E-CTG
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • single Miller I GR defects ≤3mm at upper anterior or premolar teeth
  • systemically healthy
  • identifiable cemento-enamel junction (CEJ)
  • PD ≤3 mm

Exclusion Criteria:

  • periodontal surgery experience in the past two years
  • excessive contacts
  • mobility
  • caries
  • loss of vitality
  • smoking
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    E-CTG

    SCAF

    Arm Description

    Envelope connective tissue graft

    Semilunar connective tissue graft

    Outcomes

    Primary Outcome Measures

    recession depth
    Distance between CEJ and GM
    recession depth
    Distance between CEJ and GM
    recession depth
    Distance between CEJ and GM
    recession depth
    Distance between CEJ and GM

    Secondary Outcome Measures

    recession width
    horizontal distance between two borders of recession at CEJ level
    recession width
    horizontal distance between two borders of recession at CEJ level
    recession width
    horizontal distance between two borders of recession at CEJ level
    recession width
    horizontal distance between two borders of recession at CEJ level
    probing depth
    distance between GM and base of gingival sulcus
    probing depth
    distance between GM and base of gingival sulcus
    probing depth
    distance between GM and base of gingival sulcus
    probing depth
    distance between GM and base of gingival sulcus
    clinical attachment level
    distance between CEJ and base of gingival sulcus
    clinical attachment level
    distance between CEJ and base of gingival sulcus
    clinical attachment level
    distance between CEJ and base of gingival sulcus
    clinical attachment level
    distance between CEJ and base of gingival sulcus
    keratinized tissue width
    distance between GM and MGJ
    keratinized tissue width
    distance between GM and MGJ
    keratinized tissue width
    distance between GM and MGJ
    keratinized tissue width
    distance between GM and MGJ

    Full Information

    First Posted
    September 26, 2019
    Last Updated
    September 27, 2019
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04109794
    Brief Title
    Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
    Official Title
    Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (Actual)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırıkkale 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
    42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).

    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
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    E-CTG
    Arm Type
    Active Comparator
    Arm Description
    Envelope connective tissue graft
    Arm Title
    SCAF
    Arm Type
    Active Comparator
    Arm Description
    Semilunar connective tissue graft
    Intervention Type
    Procedure
    Intervention Name(s)
    E-CTG
    Intervention Description
    Envelope connective tissue graft
    Primary Outcome Measure Information:
    Title
    recession depth
    Description
    Distance between CEJ and GM
    Time Frame
    baseline
    Title
    recession depth
    Description
    Distance between CEJ and GM
    Time Frame
    6 weeks
    Title
    recession depth
    Description
    Distance between CEJ and GM
    Time Frame
    6 months
    Title
    recession depth
    Description
    Distance between CEJ and GM
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    recession width
    Description
    horizontal distance between two borders of recession at CEJ level
    Time Frame
    baseline
    Title
    recession width
    Description
    horizontal distance between two borders of recession at CEJ level
    Time Frame
    6 weeks
    Title
    recession width
    Description
    horizontal distance between two borders of recession at CEJ level
    Time Frame
    6 months
    Title
    recession width
    Description
    horizontal distance between two borders of recession at CEJ level
    Time Frame
    12 months
    Title
    probing depth
    Description
    distance between GM and base of gingival sulcus
    Time Frame
    baseline
    Title
    probing depth
    Description
    distance between GM and base of gingival sulcus
    Time Frame
    6 weeks
    Title
    probing depth
    Description
    distance between GM and base of gingival sulcus
    Time Frame
    6 months
    Title
    probing depth
    Description
    distance between GM and base of gingival sulcus
    Time Frame
    12 months
    Title
    clinical attachment level
    Description
    distance between CEJ and base of gingival sulcus
    Time Frame
    baseline
    Title
    clinical attachment level
    Description
    distance between CEJ and base of gingival sulcus
    Time Frame
    6 weeks
    Title
    clinical attachment level
    Description
    distance between CEJ and base of gingival sulcus
    Time Frame
    6 months
    Title
    clinical attachment level
    Description
    distance between CEJ and base of gingival sulcus
    Time Frame
    12 months
    Title
    keratinized tissue width
    Description
    distance between GM and MGJ
    Time Frame
    baseline
    Title
    keratinized tissue width
    Description
    distance between GM and MGJ
    Time Frame
    6 weeks
    Title
    keratinized tissue width
    Description
    distance between GM and MGJ
    Time Frame
    6 months
    Title
    keratinized tissue width
    Description
    distance between GM and MGJ
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: single Miller I GR defects ≤3mm at upper anterior or premolar teeth systemically healthy identifiable cemento-enamel junction (CEJ) PD ≤3 mm Exclusion Criteria: periodontal surgery experience in the past two years excessive contacts mobility caries loss of vitality smoking pregnancy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35394710
    Citation
    Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.
    Results Reference
    derived

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    Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study

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