Effect of Leucocyte- and Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting

NCT06777069 | Completed DMC

• 1 other identifier: IMUH-OMFS-SG-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Autogenous palatal free gingival graft harvesting presents challenges for patients due to the increased risk of postoperative morbidity related to a second intraoral surgical wound that heals with secondary intention. This study aimed to evaluate the efficacy of the application of leukocyte- and platelet-rich fibrin (L-PRF) membrane to the palatal donor site on wound healing, hemostasis, and pain control after free gingival graft harvesting. Twenty-six adult patients with insufficient attached gingiva underwent soft tissue augmentation using free gingival grafts harvested from the palate. Patients were randomized to either an L-PRF group or a control group. In the L-PRF group, the L-PRF membrane was sutured to the donor sites, whereas in the control group, donor sites healed by secondary intention. Postoperative evaluations were conducted on days 1, 3, 5, and 7 and at weeks 2, 3, 4, 5, and 6. Donor sites were evaluated clinically for pain, burning sensation, bleeding, wound healing, and color match to adjacent tissues. Donor site wound areas were analyzed using digital images.

Conditions

Wound Healing

Keywords

free gingival graft, platelet rich fibrin, wound healing

Outcome Measures

Primary Outcomes (1)

• Donor site pain

  Pain at the donor site was assessed using a VAS (Visual Analogue Scale) of 0-10.

  Postoperative day 1 and weeks 1, 2, 3, and 4

Secondary Outcomes (5)

• Donor site burning sensation

  Postoperative day 1 and weeks 1, 2, 3, and 4

• Donor site bleeding

  Postoperative days 1, 3, 5, and 7

• Donor site color matching with the adjacent healthy tissue

  Postoperative day 1 and weeks 1, 3, and 6

• Donor site clinical healing

  Postoperative weeks 1, 2, 3, and 4

• Donor site wound area

  At baseline, on postoperative day 3, and at weeks 1, 2, 3, and 4

Study Arms (2)

Leucocyte and platelet rich fibrin (L-PRF)

EXPERIMENTAL

The L-PRF membrane was sutured to the palatal donor sites

Procedure: Leucocyte and platelet rich fibrin membrane application

Control

NO INTERVENTION

The palatal donor sites healed by secondary intention without L-PRF application

Interventions

Leucocyte and platelet rich fibrin membrane application PROCEDURE

Leukocyte and platelet rich membrane, obtained by centrifuging 10 ml of venous blood collected from the patient's antecubital vein, was sutured to the donor sites.

Leucocyte and platelet rich fibrin (L-PRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva (shallow vestibular depth, gingival recession)

You may not qualify if:

• Patients under 18 years of age
• Patients with systemic medical conditions that may compromise wound healing (e.g., uncontrolled diabetes mellitus, hypertension, blood disorders, rheumatoid arthritis)
• Patients receiving medication that may affect periodontal tissues (e.g., antibiotics, immunomodulatory drugs, steroids, non-steroidal anti-inflammatory drugs) within the last 3 months before surgery
• Patients receiving anticoagulant and antiaggregant therapy
• Smokers
• Pregnancy or breastfeeding
• History of palatal free gingival graft harvesting procedure

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Baskent University, Faculty of Dentistry, Çankaya/Ankara

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Leukocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Serap Gulsever, DDS, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after application
• Access Criteria: via e-mail

Locations

TU (1)