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NCT Number: NCT05089812

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

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.

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Key information

Conditions

Oral Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styra, 8036, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

see above

Primary outcomes

  1. Change in Swelling

    Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical

    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.

Secondary outcomes

  1. Change in Inflammatory Complications - Amount of clinical recordings

    Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical

    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)

  2. Change in Inflammatory Complications - VAS Swelling

    Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical

    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)

  3. Change in Inflammatory Complications - VAS Bleeding

    Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical

    VAS-Scale day 1-7 (Bleeding) (0 is no bleeding/good outcome, 10 is a very high amount of bleeding/bad outcome)

  4. Change in Inflammatory Complications - VAS Pain

    Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical

    VAS-Scale day 1-7 (pain) (0 is no pain/good outcome, 10 is a very bad pain/bad outcome)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: PRF

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Oct 22, 2021
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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