Oral SurgeryPRFNCT05089812
The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
A study testing Third-molar extraction using platelet-rich fibrin as a filling of the alveolus in people with Oral Surgery, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Surgery
- What is being tested?
- Third-molar extraction using platelet-rich fibrin as a filling of the alveolus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2021to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Third-molar extraction using platelet-rich fibrin as a filling of the alveolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third-molar extraction using platelet-rich fibrin as a filling of the alveolusProcedure or surgery
see above
| Study group | Role | What they receive |
|---|---|---|
| Test-Group | Experimental | PRF-Group Receives: Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus |
| Control-Group | Placebo comparator | Not described Receives: Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Secondary outcomes (4)
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)
Measured: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
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)
Measured: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
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)
Measured: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
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)
Measured: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2022
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089812
- Sponsor's protocol ID
- EK: 33-451 ex 20/21
- Acronym
- PRF
- Status last verified
- Jun 2024
- First submitted
- 11 Oct 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39467892
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
- ClinicalTrials.gov ID
- NCT05089812
- Acronym / sponsor ID
- PRF / EK: 33-451 ex 20/21
- Conditions
- Oral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Test-Group | Experimental | Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolusPRF-Group |
| Control-Group | Placebo comparator | Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third-molar extraction using platelet-rich fibrin as a filling of the alveolussee above | Procedure or surgery | Control-Group, Test-Group |
Primary outcome
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.
4 secondary outcomes
Change in Inflammatory Complications - Amount of clinical recordings
Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Change in Inflammatory Complications - VAS Swelling
Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Change in Inflammatory Complications - VAS Bleeding
Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Change in Inflammatory Complications - VAS Pain
Time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 39467892Zwittnig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third-molar extraction using platelet-rich fibrin as a filling of the alveolus in people with Oral Surgery, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Swelling (time frame: Pre-surgical and at day 1, 3, 7 and 14 post-surgical). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.