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

Study Overview
=================
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.

Official Title
-----------------
Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft

Conditions
-----------------
Pain, Wound Healing

Intervention / Treatment
-----------------
* Device: Platelet Rich Fibrin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palatal donor site received PRF<br>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<br>* Native growth factors<br>|
| Active Comparator: Palatal donor site NOT receiving PRF<br>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<br>* Native growth factors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1, 2, 3, 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in contour of the surgical area | To check for wound healing; contour of the surgical area was examined and compared to preoperative records | 1, 2, 3, 4 and 8 weeks | 
| Changes in degree of color match | To check for wound healing; degree of color match was examined and compared to preoperative records | 1, 2, 3, 4 and 8 weeks | 
| Changes in tissue texture | To check for wound healing; tissue texture was examined and compared to preoperative records | 1, 2, 3, 4 and 8 weeks |