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
About this trial
This is an interventional treatment trial for Pain
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
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
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
Learn more about this trial
Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
We'll reach out to this number within 24 hrs