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

King Abdulaziz University

Status: Completed

Conditions: Wound Healing; Pain

Treatments: Device: Platelet Rich Fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02797899

285/254/1434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Palatal donor site received PRF

Active Comparator group

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.

Treatment:

Device: Platelet Rich Fibrin

Palatal donor site NOT receiving PRF

Active Comparator group

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.

Treatment:

Device: Platelet Rich Fibrin