Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft

Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound

Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: A free gingival graft; Device: A Platelet-Rich Fibrin dressing; Device: A non-eugenol-based dressing

Detailed Description

Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva.

A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.

The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study.

Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group .

Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, 00963
    • Damascus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of Syrian descent.
• Systemically healthy.
• Attached gingival width ≤ 2 mm.
• Presence of type II (Miller Classification) of gingival recession.

Exclusion Criteria:

• Smoking.
• Pregnancy or lactating.
• Presence of any systematic diseases can affect the periodontal surgery.
• Subjects with significant moderate to severe periodontal disease.
• Patients under orthodontic treatment
• Presence of restorative materials (e.g. crown)
• Subjects have failed to maintain good plaque control.
• Subjects having previous surgical treatment for covering the recession in the chosen area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Platelet-Rich Fibrin dressing; A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft.	Procedure: A free gingival graft; A free gingival graft will be used for the treatment of gingival recession; Device: A Platelet-Rich Fibrin dressing; A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.
Experimental: A non-eugenol-based dressing; A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.	Procedure: A free gingival graft; A free gingival graft will be used for the treatment of gingival recession; Device: A non-eugenol-based dressing; A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain score using the visual analogue scale (VAS)	This variable is going to be measured by an visual analogue scale (VAS). The VAS pain scores ranges between 0 to10. (0: no pain, 1: minimal pain, 10: severe pain).	The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing index for free gingival graft	The healing index for free gingival graft is an ordinal score: very poor, poor, good, very good and excellent.	The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..
The complete re-epithelialization of the palatal wound	This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles.	The measurements will be performed at T1 (after 1 week measurement), T2 (after 2 weeks measurement), T3 (after 3 weeks measurement), and T4 (after 4 weeks measurement).
Changes in gingival recession	Miller Class II of Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.	The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Match color of the palatal wound	VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contralateral palatal mucosa.	The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).
Attached gingival width	Measured from the Mucogingival junction to the gingival Groove.	The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).
Plaque index	Score: none, simple, middle, severe.	The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Gingival Index	Score: none, simple, middle. Severe.	The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Bleeding on probing Index	Score: bleeding, none bleeding.	The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Pocket Probing Depth	Score: normal, simple, middle, severe.	The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Ali Abou Sulaiman, PhD., Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications and helpful links

General Publications

• Bansal M, Kumar A, Puri K, Khatri M, Gupta G, Vij H. Clinical and Histologic Evaluation of Platelet-Rich Fibrin Accelerated Epithelization of Gingival Wound. J Cutan Aesthet Surg. 2016 Jul-Sep;9(3):196-200. doi: 10.4103/0974-2077.191647.
• Femminella B, Iaconi MC, Di Tullio M, Romano L, Sinjari B, D'Arcangelo C, De Ninis P, Paolantonio M. Clinical Comparison of Platelet-Rich Fibrin and a Gelatin Sponge in the Management of Palatal Wounds After Epithelialized Free Gingival Graft Harvest: A Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27.
• Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 2015 Jun;42(6):582-9. doi: 10.1111/jcpe.12404. Epub 2015 May 19.
• Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-beta1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clinical Study. Photomed Laser Surg. 2016 Jun;34(6):263-71. doi: 10.1089/pho.2016.4094. Epub 2016 Apr 18. Erratum In: Photomed Laser Surg. 2018 Jan;36(1):58.
• Ustaoglu G, Ercan E, Tunali M. The role of titanium-prepared platelet-rich fibrin in palatal mucosal wound healing and histoconduction. Acta Odontol Scand. 2016 Oct;74(7):558-564. doi: 10.1080/00016357.2016.1219045. Epub 2016 Aug 19.
• Shanmugam M, Kumar TS, Arun KV, Arun R, Karthik SJ. Clinical and histological evaluation of two dressing materials in the healing of palatal wounds. J Indian Soc Periodontol. 2010 Oct;14(4):241-4. doi: 10.4103/0972-124X.76929.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: gingival recession; free gingival graft; autografts; Attached gingival width; Platelet-Rich Fibrin dressing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: UDDS-Perio-02-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No