Anti-inflammatory Effect of Platelet-Rıch Fıbrın

Comparative Investigation of Anti-inflammatory Effect of Platelet-Rıch Fıbrın After Mandibular Wisdom Tooth Surgery

This study evaluated the anti-inflammatory effect of platelet-rich fibrin (PRF) applied to the extraction socket after impacted mandibular third molar surgery with subjective and objective parameters. A total of 48 patients who had fully impacted wisdom teeth in bilateral and similar positions were included in the study. The control group was formed with the standard extraction of the lower third molars, and the PRF group was formed with local PRF application in addition to standard impacted tooth surgery (n=96). The anti-inflammatory activity of PRF on postoperative 2nd and 7th days was evaluated subjectively by clinical parameters and objectively by biochemical parameters.

Subjective parameters were pain assesment, swelling measurements on the face and limitation of mouth opening. Objective data is the analysis of serum values and anti-inflammatory markers in the blood.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgical Complication; Edema Face
• Intervention / Treatment: Other: Platelet rich fibrin application

Detailed Description

Operations All surgical procedures were performed by the same surgeon, with the same flap design and the same surgical technique. 2 ml of a local anesthetic solution containing 40 mg/ml articaine HCl and 0.006 mg/ml epinephrine HCl was used for N. alveolaris inferior and N. buccalis blockage. The mucoperiosteal flap was removed by making a horizontal incision starting from the retromolar region, through horizontally in the buccal, circular around the neck of the mandibular second molar, and continuing vertically at the mesial half of the mandibular second molar tooth. Alveolotomy and/or division of teeth and/or roots were performed with sterile tungsten carbide burs with an electric controlled motor rotating at 20,000 rpm under 0.9% saline irrigation during operation. Roots were removed from the alveoli with the help of a bein elevator placed on the buccal and/or mesial parts of the teeth. After tooth extraction, the bone, soft tissue residues, and debris in the area were removed, and the socket was irrigated with 0.9% saline. In the control group, primary suturing was performed after bleeding control without any application to the extraction socket, while in the PRF group, PRF was applied to the socket just before suturing (Fig 2). All patients were prescribed antibiotics (amoxicillin-clavulanic acid, 1gr, 2x1) (Augmentin-BID, GlaxoSmithKline, London, England), analgesic (Acetaminophen, 500 mg, 3x1) (Parol, Atabay, Istanbul, Turkey) and mouthwash (120 mg %0.12 chlorhexidine gluconate and 150 mg %0.15 benzydamine hydrochloride, 200 ml, 3x1) (Kloroben, Drogsan, Ankara, Turkey) after the surgical procedure.

PRF Preparation Blood sampling was performed through the peripheral antecubital vein by selecting a suitable branule for the patient's vascular structure with a closed vacuum system. PRFs were prepared according to the method of Choukron et al.(2001). 10 ml blood samples were inserted in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel.

Obtaining edema, pain, and serum marker data A visual analog scale (VAS) of 100 mm was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days, with 0 indicating no pain and 100 indicating the worst pain they had ever experienced. In order to evaluate the severity of edema, the tragus - buccal comissura and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded. To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups. The progression of swelling and trismus was measured in millimeters and evaluated by comparing with the value obtained at baseline14.

For objective data, ESR values were measured using the Vision ESR analyzer (YHLO Biotech Co., Shenzhen, China), and CRP values were measured using the BN II nephelometric analyzer (Siemens Healthcare Diagnostics, Marburg, Germany). IL-6 levels (pg/ml) were determined using the Human IL-6 Elisa Kit (Elabscience Biotechnology Co., Wuhan, China) and TNF-a levels (pg/ml) were determined using the Human TNF-α Elisa Kit (Elabscience Biotechnology Co., was measured using Wuhan, China).

Statistical Evaluation Data were analyzed with the IBM SPSS® V23 (IBM Company, Chicago, IL, United States) package program. Mann-Whitney U test was used to compare non-normally distributed data according to paired groups, and an independent two-sample t-test was used to compare normally distributed data. The significance level was taken as p<0.05.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Edirne, Merkez, Turkey, 22030
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• not have any systemic disease that will prevent tissue healing
• no history of regular drug use
• no drug allergies
• not smoking
• not being pregnant
• having bilateral mandibular third molar tooth in class II, position B and C position according to Pell & Gregory classification with the same root form, position and level of impaction
• no signs of abscess, pericoronitis or inflammation before extraction

Exclusion Criteria:

• pregnancy
• having a chronic disease
• having a local infection in the impacted tooth area
• smoking

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1- PRF; After wisdom tooth extraction PRF located to the extraction socket	Other: Platelet rich fibrin application; PRFs were prepared by obtaining10 ml blood samples from each patinet and inserting them in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel. After the tooth extraction in the experimental group PRF located to the extraction socket.
No Intervention: PRF free; Only surgical procedure of the wisdom tooth extraction is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema measurement	In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.	2nd day posoperatively
Edema measurement	In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.	7th day posoperatively
Trismus measurement	To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.	2nd day postoperatively
Trismus measurement	To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.	7th day postoperatively
Pain assesment	A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.	2nd day postoperatively
Pain assesment	A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.	7th day postoperatively
Erythrocyte sedimentation rate (ESR)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	2nd day postoperatively
Erythrocyte sedimentation rate (ESR)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	7th day postoperatively
C-reactive protein (CRP)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	2nd day postoperatively
C-reactive protein (CRP)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	7th day postoperatively
interleukin 6 (IL-6)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	2nd day postoperatively
interleukin 6 (IL-6)	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	7th day postoperatively
tumor necrosis factor-alpha (TNF-α )	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	2nd day postoperatively
tumor necrosis factor-alpha (TNF-α )	A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response	7th day postoperatively

Collaborators and Investigators

• Sponsor: Nilay Er
• Investigators: Principal Investigator: Nilay Er, Trakya University

Publications and helpful links

General Publications

• Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
• Dar MM, Shah AA, Najar AL, Younis M, Kapoor M, Dar JI. Healing Potential of Platelet Rich Fibrin in Impacted Mandibular Third Molar Extraction Sockets. Ann Maxillofac Surg. 2018 Jul-Dec;8(2):206-213. doi: 10.4103/ams.ams_181_18.
• Ozgul O, Senses F, Er N, Tekin U, Tuz HH, Alkan A, Kocyigit ID, Atil F. Efficacy of platelet rich fibrin in the reduction of the pain and swelling after impacted third molar surgery: randomized multicenter split-mouth clinical trial. Head Face Med. 2015 Nov 26;11:37. doi: 10.1186/s13005-015-0094-5.
• Litao MK, Kamat D. Erythrocyte sedimentation rate and C-reactive protein: how best to use them in clinical practice. Pediatr Ann. 2014 Oct;43(10):417-20. doi: 10.3928/00904481-20140924-10.
• Sahibzada HA, Khurshid Z, Khan RS, Naseem M, Siddique KM, Mali M, Zafar MS. Salivary IL-8, IL-6 and TNF-alpha as Potential Diagnostic Biomarkers for Oral Cancer. Diagnostics (Basel). 2017 Apr 9;7(2):21. doi: 10.3390/diagnostics7020021.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): August 22, 2021

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: edema; trismus; platelet-rich-fibrin; Serum markers
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PRF2022

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