NCT05336578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 6, 2022

Last Update Submit

April 13, 2022

Conditions

Surgical ComplicationPain, PostoperativeEdema Face

Keywords

platelet-rich-fibrinedemaSerum markerstrismus

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

1- PRF

EXPERIMENTAL

After wisdom tooth extraction PRF located to the extraction socket

Other: Platelet rich fibrin application

PRF free

NO INTERVENTION

Only surgical procedure of the wisdom tooth extraction is performed

Interventions

Platelet rich fibrin applicationOTHER

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.

1- PRF

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 21740371RESULT

  • 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.

    PMID: 30693233RESULT

  • 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.

    PMID: 26607842RESULT

  • 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.

    PMID: 25290132RESULT

  • 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.

    PMID: 28397778RESULT

MeSH Terms

Conditions

Pain, PostoperativeEdemaTrismus

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Study Officials

  • Nilay Er

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 20, 2022

Study Start

October 10, 2019

Primary Completion

February 10, 2020

Study Completion

August 22, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)