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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589235
• Other study ID #: UDDS-Perio-02-2018
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: July 2019
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View Citation

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 R — View Citation

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. — View Citation

Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-ß1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clin — View Citation

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. — View Citation

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. Epub 2016 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)..
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).