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

NCT02797899 | Completed

• 1 other identifier: 285/254/1434
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in contour of the surgical area

  1, 2, 3, 4 and 8 weeks

• Changes in degree of color match

  1, 2, 3, 4 and 8 weeks

• Changes in tissue texture

  1, 2, 3, 4 and 8 weeks

Study Arms (2)

Palatal donor site received PRF

ACTIVE COMPARATOR

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

Palatal donor site NOT receiving PRF

ACTIVE COMPARATOR

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

Interventions

Platelet Rich Fibrin DEVICE

Native growth factors

Palatal donor site NOT receiving PRF; Palatal donor site received PRF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• lack of keratinized tissue in the mandibular central incisor region

You may not qualify if:

• smoking
• uncontrolled systemic disease that might contraindicate periodontal surgery
• severe gag reflex preventing maxillary surgical procedure
• inability or unwillingness to provide informed consent

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Consultant of Periodontology

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 14, 2016
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share