Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing

Platelet Rich Fibrin Accelerates Wound Healing and Reduces Postoperative Complications of Palatal Subepithelial Connective Tissue Donor Site: a Controlled Randomized Clinical Trial

Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues. Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia. Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement.Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after a subepithelial connective tissue graft procedure at palatal donor site.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Wound Healing; Bleeding Wound
• Intervention / Treatment: Procedure: connective tissue graft; Procedure: connective tissue graft&PRF; Other: connective tissue graft&PRF

Detailed Description

Successful treatment of gingival recession (GR) is based on the use of clinically predictable periodontal plastic surgery (PPS) procedures. There are many procedures and different surgical procedures were proposed. Coronally advanced flap and subepithelial connective tissue graft (SCTG) is a good combination to increase the keratinized tissue width and reduce the amount of gingival recession.

SCTG has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues.

Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia.

Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement. The three-dimensional fibrin network and presence of many growth factors such as fibroblast growth factor, platelet-derived growth factor (PDGF) and epidermal growth factor supports effective neovascularization, accelerated wound closure and rapid cicatricial tissue remodeling. The strong fibrin architecture distinguishes it from other kinds of platelets concentrates and it seems responsible for the slow release of growth factors over a period of 7-14 days5. This period is seen as sufficient to prevent complications after connective tissue graft. Since the first description by Choukroun in 2000, PRF has been used in the clinical field for more than a decade in oral surgery and implant dentistry.

Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after connective tissue graft procedure at palatal donor site.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Deni̇zli̇
    • Denizli, Deni̇zli̇, Turkey, 20070
      • Pamukkale University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• who needed connective tissue graft for treating gingival recessions were included

Exclusion Criteria:

• Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
• smoking,
• nausea
• pregnancy/lactation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: connective tissue graft; Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: 5/0 silk suture	Procedure: connective tissue graft; anesthesia of the palatal mucosa; subepithelial connective tissue graft harvesting; suturing (5/0 silk suture); Procedure: connective tissue graft&PRF; anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture); Other: connective tissue graft&PRF; taking blood from patient; centrifuging blood; obtain PRF
Experimental: connective tissue graft&PRF; Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture	Procedure: connective tissue graft; anesthesia of the palatal mucosa; subepithelial connective tissue graft harvesting; suturing (5/0 silk suture); Procedure: connective tissue graft&PRF; anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture); Other: connective tissue graft&PRF; taking blood from patient; centrifuging blood; obtain PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defining wound healing to 40 patient with early healing index	to inspect the early wound healing on donor site on palate using early healing index on 3rd, 7th and 14th postoperatively. (1) complete flap closure, no fibrin line in the interproximal area; (2) complete flap closure, fine fibrin line in the interproximal area; (3) complete flap closure, fibrin clot in the interproximal area; (4) incomplete flap closure, partial necrosis of the interproximal tissue; and (5) incomplete flap closure, complete necrosis of the interproximal tissue	14 days
postoperative pain	Patients were instructed to complete pain diary for the day at the surgery, first day, third day, seventh day, tenth day after surgery. The visual analog scale (VAS) that consists of a 10-cm line anchored by 2 extremes was used for perception measurements . Total score was 100 and less score was 0 according to this scale. According to this scale "0" means no pain, no discomfort during chewing and speaking, while the "100",meant 'worst pain, extreme discomfort during chewing and speaking'	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative bleeding	Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.	7days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue colour match	On days 3, 7, 14 , the color of the palatal mucosa was assessed by the VAS score with the adjacent and opposite mucosa color. In this evaluation, 0 points showed no color matching, and 100 points showed excellent color matching with evaluated tissues	14 days

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Murat AKGUL, prof. dr., Pamukkale University Faculty of Dentistry Department of Periodontolgy

Publications and helpful links

General Publications

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: VAS; connective tissue graft; platelet rich fibrin; patient perceptions
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Wounds and Injuries
• Other Study ID Numbers: 60116787-020/44407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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