Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series

Phase 4

Completed

• Conditions: Platelets Rich Fibrin, Palatal Donor Tissue
• Interventions: Biological: Platelets Rich Fibrin in healing of palatal donor tissue; Other: Placebo

• Registration Number: NCT02521467
• Lead Sponsor: Ain Shams University

Brief Summary

Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.

Detailed Description

Introduction:

Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.

Materials and methods:

Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study First Submitted: 2015-07-28
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-10
• Last Update Submitted: 2015-08-10
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation

Exclusion Criteria

• High arched palate, medically compromised

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF	Platelets Rich Fibrin in healing of palatal donor tissue	Platelets Rich Fibrin
palatal stent	Placebo	Palatal stent

Primary Outcome Measures

Name	Time	Method
Pain Assessment by Visual Analog Scale (VAS)	1 week postoperative	VAS ranged from 0 (no pain ) to 10 (severe pain)
Clinical healing of the palate	2 weeks postoperative	color match, consistency and thickness of palate (Composite measure)