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

NCT03734328 | Completed DMC

• 1 other identifier: 60116787-020/44407
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Healing; Pain, Postoperative; Bleeding Wound

Keywords

connective tissue graft; platelet rich fibrin; patient perceptions; VAS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• postoperative bleeding

  7days

Other Outcomes (1)

• Tissue colour match

  14 days

Study Arms (2)

connective tissue graft

ACTIVE COMPARATOR

Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: * 5/0 silk suture

Procedure: connective tissue graft; Procedure: connective tissue graft&PRF; Other: connective tissue graft&PRF

connective tissue graft&PRF

EXPERIMENTAL

Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture

Procedure: connective tissue graft; Procedure: connective tissue graft&PRF; Other: connective tissue graft&PRF

Interventions

connective tissue graft PROCEDURE

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

connective tissue graft; connective tissue graft&PRF

connective tissue graft&PRF PROCEDURE

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

connective tissue graft; connective tissue graft&PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry

Denizli, Deni̇zli̇, 20070, Turkey (Türkiye)

Location

Related 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. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 BACKGROUND

• 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.

  PMID: 26313017 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Murat AKGUL, prof. dr.

  Pamukkale University Faculty of Dentistry Department of Periodontolgy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 7, 2018
• Study Start: June 30, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)