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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797899
• Other study ID #: 285/254/1434
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2024
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Wound Healing
• Wounds and Injuries

Intervention

Device:
• Platelet Rich Fibrin
Native growth factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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