Anti-inflammatory Effect of Platelet-Rıch Fıbrın
Primary Purpose
Surgical Complication, Pain, Postoperative, Edema Face
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Platelet rich fibrin application
Sponsored by

About this trial
This is an interventional diagnostic trial for Surgical Complication focused on measuring platelet-rich-fibrin, edema, Serum markers, trismus
Eligibility Criteria
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
Sites / Locations
- Trakya University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1- PRF
PRF free
Arm Description
After wisdom tooth extraction PRF located to the extraction socket
Only surgical procedure of the wisdom tooth extraction is performed
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Erythrocyte sedimentation rate (ESR)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Erythrocyte sedimentation rate (ESR)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
C-reactive protein (CRP)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
C-reactive protein (CRP)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
interleukin 6 (IL-6)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
interleukin 6 (IL-6)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
tumor necrosis factor-alpha (TNF-α )
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
tumor necrosis factor-alpha (TNF-α )
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05336578
Brief Title
Anti-inflammatory Effect of Platelet-Rıch Fıbrın
Official Title
Comparative Investigation of Anti-inflammatory Effect of Platelet-Rıch Fıbrın After Mandibular Wisdom Tooth Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
August 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nilay Er
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Complication, Pain, Postoperative, Edema Face
Keywords
platelet-rich-fibrin, edema, Serum markers, trismus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1- PRF
Arm Type
Experimental
Arm Description
After wisdom tooth extraction PRF located to the extraction socket
Arm Title
PRF free
Arm Type
No Intervention
Arm Description
Only surgical procedure of the wisdom tooth extraction is performed
Intervention Type
Other
Intervention Name(s)
Platelet rich fibrin application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Edema measurement
Description
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.
Time Frame
2nd day posoperatively
Title
Edema measurement
Description
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.
Time Frame
7th day posoperatively
Title
Trismus measurement
Description
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.
Time Frame
2nd day postoperatively
Title
Trismus measurement
Description
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.
Time Frame
7th day postoperatively
Title
Pain assesment
Description
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.
Time Frame
2nd day postoperatively
Title
Pain assesment
Description
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.
Time Frame
7th day postoperatively
Title
Erythrocyte sedimentation rate (ESR)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
2nd day postoperatively
Title
Erythrocyte sedimentation rate (ESR)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
7th day postoperatively
Title
C-reactive protein (CRP)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
2nd day postoperatively
Title
C-reactive protein (CRP)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
7th day postoperatively
Title
interleukin 6 (IL-6)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
2nd day postoperatively
Title
interleukin 6 (IL-6)
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
7th day postoperatively
Title
tumor necrosis factor-alpha (TNF-α )
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
2nd day postoperatively
Title
tumor necrosis factor-alpha (TNF-α )
Description
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Time Frame
7th day postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay Er
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University
City
Edirne
State/Province
Merkez
ZIP/Postal Code
22030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21740371
Citation
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.
Results Reference
result
PubMed Identifier
30693233
Citation
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.
Results Reference
result
PubMed Identifier
26607842
Citation
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.
Results Reference
result
PubMed Identifier
25290132
Citation
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.
Results Reference
result
PubMed Identifier
28397778
Citation
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.
Results Reference
result
Learn more about this trial
Anti-inflammatory Effect of Platelet-Rıch Fıbrın
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