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

NCT ID: NCT05089812

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-03-30

Brief 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.

Conditions

Oral Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test-Group

PRF-Group

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

see above

Control-Group

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: PROCEDURE

see above

Interventions

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

see above

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz

Graz, Styra, Austria

Countries

Austria

References

Zwittnig K, Kirnbauer B, Truschnegg A, Jakse N, Wolf A, Sokolowski A, Mischak I, Payer M. Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study. Clin Oral Investig. 2024 Oct 29;28(11):615. doi: 10.1007/s00784-024-06002-9.

Reference Type: DERIVED

PMID: 39467892 (View on PubMed)

Other Identifiers

EK: 33-451 ex 20/21

Identifier Type: -

Identifier Source: org_study_id