Clinical trial NCT05089812: The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
Official title: The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Surgery
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Swelling
timeFrame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary outcomes:
measure: Change in Inflammatory Complications - Amount of clinical recordings
timeFrame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
measure: Change in Inflammatory Complications - VAS Swelling
timeFrame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
measure: Change in Inflammatory Complications - VAS Bleeding
timeFrame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
measure: Change in Inflammatory Complications - VAS Pain
timeFrame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styra
Study officials:
References: