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

M

Medical University of Graz

Status

Completed

Conditions

Oral Surgery

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05089812
EK: 33-451 ex 20/21

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups, including a placebo group

Test-Group
Experimental group
Description:
PRF-Group
Treatment:
Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus
Control-Group
Placebo Comparator group
Treatment:
Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus

Trial contacts and locations

1

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Central trial contact

Katharina Zwittnig, MD; Michael Payer, MD

Data sourced from clinicaltrials.gov

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