Clinical trial NCT02797899: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Wound Healing
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Visual Analog scale (VAS)
timeFrame: 1, 2, 3, 4 and 8 weeks
Secondary outcomes:
measure: Changes in contour of the surgical area
timeFrame: 1, 2, 3, 4 and 8 weeks
measure: Changes in degree of color match
timeFrame: 1, 2, 3, 4 and 8 weeks
measure: Changes in tissue texture
timeFrame: 1, 2, 3, 4 and 8 weeks
Other outcomes:
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Study officials:
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