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

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ClinicalTrials.gov Identifier: NCT02797899
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Maha A. Bahammam, King Abdulaziz University

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.


Condition or disease Intervention/treatment Phase
Pain Wound Healing Device: Platelet Rich Fibrin Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Palatal donor site received PRF
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.
Device: Platelet Rich Fibrin
Native growth factors

Active Comparator: Palatal donor site NOT receiving PRF
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.
Device: Platelet Rich Fibrin
Native growth factors




Primary Outcome Measures :
  1. Changes in Visual Analog scale (VAS) [ Time Frame: 1, 2, 3, 4 and 8 weeks ]
    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 :
  1. Changes in contour of the surgical area [ Time Frame: 1, 2, 3, 4 and 8 weeks ]
    To check for wound healing; contour of the surgical area was examined and compared to preoperative records

  2. Changes in degree of color match [ Time Frame: 1, 2, 3, 4 and 8 weeks ]
    To check for wound healing; degree of color match was examined and compared to preoperative records

  3. Changes in tissue texture [ Time Frame: 1, 2, 3, 4 and 8 weeks ]
    To check for wound healing; tissue texture was examined and compared to preoperative records



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Maha A. Bahammam, Associate Professor and Consultant of Periodontology, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02797899     History of Changes
Other Study ID Numbers: 285/254/1434
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Wounds and Injuries