The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions

Oral Surgery Clinical Trial

— PRF  

Official title:

The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089812
• Other study ID #: EK: 33-451 ex 20/21
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Medical University of Graz
• Contact: Michael Payer, MD
• Phone: +43 316 385 12936
• Email: mi.payer[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The fear of oral surgeries is mostly dedicated to pain and swelling in the following days. It is not surprising, that it is of high interest to do anything to reduce these consequences. Maybe this is a reason, why using platelet concentrates in oral health rehabilitation has become common in the last couple of years. Less swelling, less pain, quicker healing. The aims of the present study are to determine the effect of a platelet rich fibrin on postsurgical inflammatory complications and patient-centred outcomes and perceptions, in patients undergoing third molar extractions by split mouth technique.

25 medically healthy adults will be assigned to one of 2 groups (1 test- and 1 control group). This means due to the split mouth technique patients undergo a third molar extraction twice. The first time the patient will be randomly assigned to the test- or control group and the second time the patient will be in the other group (test or control group).

The test groups socket will be filled with a PRF (platelet-rich fibrin)-Clot before suturing the wound during third molar surgery. As well, a blood count and coagulations values will be determined. The control group will be operated conventionally. Swelling will be measured at day 1, 3 and 7 post surgery by CBCT (cone-beam computed tomography) facial scan. Subjects will be examined clinically by examiners at the seventh day after surgery for postoperative complications. In addition, Visual analogue scores (VAS) on pain, swelling and bleeding will be obtained from the patients from day 0 through day 7. The present study will answer an important clinical question with regards to the recommendation of platelet-rich fibrin usage to prevent post-operative complications with third molar surgery and to recommend a platelet-rich fibrin, if required.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Medically healthy adult [ASA (American Society of Anesthesiologists) classification I-II], age = 16 years old

• Preferably non-smoker, or previous smoker (quit = 5 years), light smoker with less than 20 cigarettes/ day

• Therapeutic or strategic indications

• No allergies against local anasthesia (Articain, Mepivacain) and their preservatives (Natriummetabisulfid E223, natriumchlorid)

• Written consent of the patient

• No infected upper and lower third molars

• Third molars in 4 quadrants and located in maxilla/mandible (classification of Pell and Gregory/ Winter) and indication for extractions

Exclusion Criteria:

• Medically compromised subjects (ASA classification III-V)

• General contraindications against third molar extractions (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)

• Treatment or diseases that may have an effect on bone turnover or bone or non-mineralized tissue metabolism (e.g. Bisphosphonates or local radio-therapy)

• Patients with anticoagulant therapy

• Heavy smoker or previous heavy smoker (quit < 5 years; = 20 cigarettes/day)

• Use of any form of antibiotics in the last 3 months or subjects requiring antibiotic prophylaxis prior to dental treatment

• Pregnant or breast feeding. Self declared intend to conceive. A pregnancy test performed for female patients.

• Subjects aged < 16 years old

Related Conditions & MeSH terms

• Oral Surgery

Intervention

Procedure:
• Third-molar extraction using platelet-rich fibrin as a filling of the alveolus
see above

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styra

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Swelling	Buccal swelling will be measured manually as well as within creating a 3D face scan pre-surgical and at day 1, 3, 7 and 14 post-surgical. Scans will be superimposed and compared with Romexis software. Manual measurement: Lines between lateral corner of the eye- jaw angle, Tragus- outer Mouth corner, Tragus-Pogonion will be measured in mm and be compared pre-surgical and at day 1, 3, 7 and 14 post-surgical. longer lines suggest more swelling and a worse outcome.	Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary	Change in Inflammatory Complications - Amount of clinical recordings	Clinical recordings of post-surgical inflammatory complications (like issue of purulent matter, restriction of the opening of the mouth, clinical attachment loss of second molar distal, flap closure)	Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary	Change in Inflammatory Complications - VAS Swelling	VAS-Scale day 1-7 (Swelling). Scale from 0-10 (0 is no swelling/good outcome, 10 is a very high amount of swelling/bad outcome)	Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary	Change in Inflammatory Complications - VAS Bleeding	VAS-Scale day 1-7 (Bleeding) (0 is no bleeding/good outcome, 10 is a very high amount of bleeding/bad outcome)	Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary	Change in Inflammatory Complications - VAS Pain	VAS-Scale day 1-7 (pain) (0 is no pain/good outcome, 10 is a very bad pain/bad outcome)	Pre-surgical and at day 1, 3, 7 and 14 post-surgical