Platelet rich fibrin effects on third molar surgery

ISRCTN ISRCTN16849867
DOI https://doi.org/10.1186/ISRCTN16849867
Secondary identifying numbers N/A
Submission date
06/03/2017
Registration date
10/03/2017
Last edited
26/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Impacted mandibular third molar extraction (also known as wisdom teeth removal) is one of the most common operations in oral and maxillofacial (mouth and teeth) surgery. Wisdom teeth grow at the back of the mouth and are the last teeth that come up through the gums, usually when people are young adults. Due to a lack of space, wisdom teeth can come through the gums on an angle causing them to be impacted. This usually means they need to be removed surgically. The operation consists of a small cut into the gum, extracting (removing) the tooth and then stitching up the area where the tooth was. Usually, the wound heals within a week or two however patients can experience some pain and are at risk of developing dry socket (a dull ache in the gum or jaw and a bad smell or taste coming from the area the tooth was removed). In order to encourage healing, platelet rich fibrin (PRF) has been suggested to be used on the tooth removal area. PRF is collected from the patients’ blood and is then processed to separate out the platelets in order to be placed on the site where the tooth was removed. PRF is thought to help increase healing and reduce the possibility of complications. The aim of this study is to see how well PRF helps reduce edema (swelling) and pain after impacted mandibular third molars surgery.

Who can participate?
Adults aged 17-27 who require the removal of their impacted mandibular third molar.

What does the study involve?
Participants give a small sample of blood which is then processed in order to separate out the PRF. Participants then undergo the removal of their wisdom teeth in their lower jaw. Both of the lower wisdom teeth (right and left) are removed according to the standard level of care. However, the right side tooth removal area receives PRF (placed on the area with dental forceps (tool)) and the left side tooth removal area does not receive PRF. Both tooth removal areas are stitched up. Participants receive follow up for seven days after the procedure where they are tested for pain and edema.

What are the possible benefits and risks of participating?
Participants may benefit from a shorter recovery time. There are no notable risks with participating however participants may feel some discomfort when giving the blood sample.

Where is the study run from?
Ankara University Dentistry Faculty Oral and Maxillofacial Surgery Department (Turkey)

When is the study starting and how long is it expected to run for?
June 2011 to October 2013

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Mehmet Fatih Şentürk
mehmetsenturk@sdu.edu.tr

Contact information

Dr Mehmet Fatih Şentürk
Scientific

Suleyman Demirel University
Dentistry Faculty
OMFS Dept.
Çünür
Isparta
06500
Türkiye

Phone +90 (0)536 333 0252
Email mehmetsenturk@sdu.edu.tr

Study information

Study designProspective split-mouth randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet ISRCTN16849867_PIS_07Mar17_Turkish.pdf
Scientific titleEffect of platelet rich fibrin on edema and pain following third molar surgery: A split mouth control study
Study objectivesThe aim of this study is to evaluate the efficacy of platelet-rich fibrine (PRF) on postoperative edema and pain after impacted mandibular third molar surgery.
Ethics approval(s)Local Ethical Committee of the Ankara University Faculty of Dentistry, 28/11/2011, ref: 25/1
Health condition(s) or problem(s) studiedBilateral impacted third molars
InterventionParticipants are selected based off their need for the removal of bilaterally (right-left) impacted mandibular third molars.

Prior to the procedure, participants have blood collected. After placing the collected blood in a centrifuge for 12 minutes to separate the different components, the platelet rich fibrin (PRF) is collected and prepared to be applied to the patient.

Participants then have both their left and right mandibular third molar extracted (done to the standard level of care). After extraction, participants receive PRF only to the right tooth extraction area. The left tooth extraction area does not receive anything. Both extraction sits are sutured. PRF is placed into the extraction area (tooth socket) using dental forceps.

Participants are followed up for seven days after the study. Follow up involves measurements of participants pain and edema of the extraction areas and takes place at the Ankara University Dentistry faculty Oral and Maxillofacial Surgery department. For standardisation reasons, all measurements are done by the same surgeon.
Intervention typeProcedure/Surgery
Primary outcome measurePain is measured using a visual analogue scale (VAS) and Verbal rate scale (VRS) at 6 and 12 hours and 1, 2, 3 and 7 days after surgery.
Secondary outcome measuresEdema is measured using a flexible ruler at baseline, 2 and 7 days.
Overall study start date06/06/2011
Completion date19/10/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. Healthy patients without significant medical diseases or a history of bleeding problems
2. Symmetrical impacted third molars which feature the same level of surgical difficulty that require the same surgical technique to be performed
3. The third molars in the Class I, Level B position (according to Pell &Gregory) and in the vertical positions according to Winter
4. Aged 17–27 years
Key exclusion criteria1. Pregnant and lactating women
2. Signs of pericoronitis
3. Chronic use of medications such as antihistamines, non-steroidal anti-inflammatory drugs (NSAID), steroids and antidepressants which would complicate the evaluation of their postoperative response
Date of first enrolment03/09/2012
Date of final enrolment01/05/2013

Locations

Countries of recruitment

  • Türkiye

Study participating centre

Ankara University Dentistry Faculty Oral and Maxillofacial Surgery Department
Emniyet Mahallesi
Ankara
06500
Türkiye

Sponsor information

Ankara University
Hospital/treatment centre

Dentistry Faculty
Oral and Maxillofacial Surgery Department
Besevler
Ankara
06500
Türkiye

Phone +90 (0)312 296 5576
Email fatih.senturk84@gmail.com
Website dentistry.ankara.edu.tr
ROR logo "ROR" https://ror.org/01wntqw50

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Uğur Gülşen (ugrgulsen@gmail.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 07/03/2017 14/03/2017 No Yes
Results article results 24/04/2017 Yes No

Additional files

ISRCTN16849867_PIS_07Mar17_Turkish.pdf
Uploaded 14/03/2017

Editorial Notes

26/04/2017: Publication reference added.