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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734328
• Other study ID #: 60116787-020/44407
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Wound
• Pain, Postoperative
• Postoperative Complications
• Wound Healing
• Wounds and Injuries

Intervention

Procedure:
• connective tissue graft
anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting suturing (5/0 silk suture)
• 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

Locations

Country	Name	City	State
Turkey	Pamukkale University Faculty of Dentistry	Denizli	Deni?zli?

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — 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 Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	postoperative bleeding	Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.	7days