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The Use of Cyanoacrylate on Palatal Wound

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Free gingival graft
Cyanoacrylate application
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

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

Inclusion Criteria:

  • no systemic diseases
  • no coagulation disorders
  • no drug intake in the previous 6 months that might effect the periodontal health status
  • no pregnancy or lactation
  • no smoking habit
  • <1 mm attached gingiva width on one or two lower anterior teeth
  • Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)

Exclusion Criteria:

  • Hematologic disorders
  • No cooperation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Periacryl group

    Control group

    Arm Description

    Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis

    Free gingival graft was harvested from palatal region and left to heal without applying periacryl.

    Outcomes

    Primary Outcome Measures

    Primary bleeding time
    The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.

    Secondary Outcome Measures

    Visual Analog Scale (VAS)
    The changes in postoperative pain level after the operation
    Analgesic consumption
    The changes in the number of painkiller taken to relieve pain after the operation
    Completion of epithelization
    The epithelization assessed by the peroxide test

    Full Information

    First Posted
    August 3, 2017
    Last Updated
    September 1, 2017
    Sponsor
    T.C. ORDU ÜNİVERSİTESİ
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273010
    Brief Title
    The Use of Cyanoacrylate on Palatal Wound
    Official Title
    The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (Actual)
    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
    T.C. ORDU ÜNİVERSİTESİ

    4. Oversight

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

    5. Study Description

    Brief Summary
    The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.
    Detailed Description
    A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate. Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Periacryl group
    Arm Type
    Experimental
    Arm Description
    Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Free gingival graft was harvested from palatal region and left to heal without applying periacryl.
    Intervention Type
    Procedure
    Intervention Name(s)
    Free gingival graft
    Intervention Description
    Free gingival graft was harvested from palatal donor site
    Intervention Type
    Procedure
    Intervention Name(s)
    Cyanoacrylate application
    Intervention Description
    Periacyrl was applied on palatal wounds
    Primary Outcome Measure Information:
    Title
    Primary bleeding time
    Description
    The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS)
    Description
    The changes in postoperative pain level after the operation
    Time Frame
    1-7 days after operation
    Title
    Analgesic consumption
    Description
    The changes in the number of painkiller taken to relieve pain after the operation
    Time Frame
    1-7 days after operation
    Title
    Completion of epithelization
    Description
    The epithelization assessed by the peroxide test
    Time Frame
    Once a week for a month after the operation

    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: no systemic diseases no coagulation disorders no drug intake in the previous 6 months that might effect the periodontal health status no pregnancy or lactation no smoking habit <1 mm attached gingiva width on one or two lower anterior teeth Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm) Exclusion Criteria: Hematologic disorders No cooperation

    12. IPD Sharing Statement

    Learn more about this trial

    The Use of Cyanoacrylate on Palatal Wound

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