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Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft

Primary Purpose

Pain, Wound Healing

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Platelet Rich Fibrin
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

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

Inclusion Criteria:

  • lack of keratinized tissue in the mandibular central incisor region

Exclusion Criteria:

  • smoking
  • uncontrolled systemic disease that might contraindicate periodontal surgery
  • severe gag reflex preventing maxillary surgical procedure
  • inability or unwillingness to provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Palatal donor site received PRF

    Palatal donor site NOT receiving PRF

    Arm Description

    Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and received platelet rich fibrin and periodontal pack as assigned randomly by a flip of coin during the screening visits.

    Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and sutured followed by periodontal pack application.

    Outcomes

    Primary Outcome Measures

    Changes in Visual Analog scale (VAS)
    a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represent their level of perceived pain

    Secondary Outcome Measures

    Changes in contour of the surgical area
    To check for wound healing; contour of the surgical area was examined and compared to preoperative records
    Changes in degree of color match
    To check for wound healing; degree of color match was examined and compared to preoperative records
    Changes in tissue texture
    To check for wound healing; tissue texture was examined and compared to preoperative records

    Full Information

    First Posted
    June 2, 2016
    Last Updated
    June 13, 2016
    Sponsor
    King Abdulaziz University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02797899
    Brief Title
    Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
    Official Title
    Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Abdulaziz University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores. Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form. The palatal donor area were evaluated for complete wound healing records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
    Detailed Description
    Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is still commonly used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and subsequently decrease pain scores. Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base line. The palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Wound Healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Palatal donor site received PRF
    Arm Type
    Active Comparator
    Arm Description
    Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and received platelet rich fibrin and periodontal pack as assigned randomly by a flip of coin during the screening visits.
    Arm Title
    Palatal donor site NOT receiving PRF
    Arm Type
    Active Comparator
    Arm Description
    Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and sutured followed by periodontal pack application.
    Intervention Type
    Device
    Intervention Name(s)
    Platelet Rich Fibrin
    Intervention Description
    Native growth factors
    Primary Outcome Measure Information:
    Title
    Changes in Visual Analog scale (VAS)
    Description
    a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represent their level of perceived pain
    Time Frame
    1, 2, 3, 4 and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in contour of the surgical area
    Description
    To check for wound healing; contour of the surgical area was examined and compared to preoperative records
    Time Frame
    1, 2, 3, 4 and 8 weeks
    Title
    Changes in degree of color match
    Description
    To check for wound healing; degree of color match was examined and compared to preoperative records
    Time Frame
    1, 2, 3, 4 and 8 weeks
    Title
    Changes in tissue texture
    Description
    To check for wound healing; tissue texture was examined and compared to preoperative records
    Time Frame
    1, 2, 3, 4 and 8 weeks

    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: lack of keratinized tissue in the mandibular central incisor region Exclusion Criteria: smoking uncontrolled systemic disease that might contraindicate periodontal surgery severe gag reflex preventing maxillary surgical procedure inability or unwillingness to provide informed consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft

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