Wisdom Tooth RemovalNCT06823934
Evaluation of the Effects of A-Prf and Oral Dexamethasone Use in Third Molar Extraction
A study testing Impacted lower wisdom tooth extraction in people with Wisdom Tooth Removal, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Impacted third molar tooth extraction is one of the most frequently performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the patient's quality of life in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wisdom Tooth Removal
- What is being tested?
- Impacted lower wisdom tooth extraction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2021to 15 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not having any systemic disease,
- Being over 18 years of age,
- Bilateral teeth being in similar positions and being completely impacted,
- Not having any allergies to the drugs to be used in the study.
Who cannot join
- Infection in the area where the extraction will be performed,
- Pregnancy or breastfeeding,
- Using medication up to 2 weeks before tooth extraction,
- Not using prescribed medications regularly,
- Not coming to regular check-ups.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Van, 65080
About this study
Official title: Evaluation of the Effects of A-Prf and Oral Dexamethasone Use on Postoperative Complications in Third Molar Tooth Extraction
Impacted third molar tooth extraction is one of the most frequently performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the patient's quality of life in the postoperative period. Today, there are many methods used to prevent or treat these complications. Corticosteroid use and A-PRF biomaterial obtained from the patient's own blood are some of these methods. In patients with bilaterally impacted lower wisdom teeth, A-PRF was applied to one side after extraction and postoperative oral dexamethasone was used to the other side. Intra-group and inter-group evaluations were made by collecting the patients' pain, edema, trismus and analgesic use data.
Read the detailed description
Impacted third molar tooth extraction is one of the most commonly performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the quality of life of the patient in the postoperative period and may cause patients to avoid this procedure. Today, there are many methods used to prevent or treat these complications. The use of corticosteroids and the A-PRF biomaterial obtained from the patient's own blood are some of these methods. No study has been found in the literature comparing the effects of oral use of dexamethasone, a corticosteroid drug, with A-PRF on pain, edema, trismus and analgesic use. In patients with bilateral impacted lower wisdom teeth, A-PRF was applied to the extraction site after extraction on one side and postoperative oral dexamethasone was used on the other side. Pain, edema, trismus and analgesic use data of the patients were collected and in-group and intergroup evaluations were made.
- Conditions
- Wisdom Tooth Removal
- Being tested
- Impacted lower wisdom tooth extraction
- Keywords
- Third Molar A-PRF, Dexamethasone, Postoperative Complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted lower wisdom tooth extractionProcedure or surgery
One of the most common operations performed in oral surgery is the extraction of lower impacted wisdom teeth. The extraction of impacted third molars causes significant inflammatory changes resulting in edema, trismus and pain. Complications encountered after the extraction of lower impacted wisdom teeth can negatively affect the daily lives of patients. Some of the treatments applied for these complications can be listed as drug use, cold/hot compression, low-dose laser therapy, cryotherapy, autogenous biomaterials such as PRF.
| Study group | Role | What they receive |
|---|---|---|
| Oral Dexamethasone | Active comparator | After the extraction of the impacted wisdom tooth, the patient was prescribed oral dexamethasone (Dekort 4mg tablet, S:3*1 DEVA brand) for 3 days. Receives: Procedure: Impacted lower wisdom tooth extraction |
| A-Prf | Active comparator | A-PRF was placed in the patients' tooth extraction sockets and the flap was closed primarily using 3/0 silk sutures. Receives: Procedure: Impacted lower wisdom tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Mouth Opening
For the evaluation of the maximum mouth opening of the patients, the maximum mouth opening and the distance between the incisal edges of the central teeth in the most open position of the mouth were measured before the operation, on the 2nd day after the operation, on the 7th day, 14th day and 30th day after the operation.
Measured: Preoperative and postoperative 2nd, 7th, 14th and 30th days
Edema
For the evaluation of edema of the patients, face measurements between angulus-tragus, angulus-lateral canthus, angulus-nasal wing, angulus-labial commissure, and angulus-pogonion were made before the operation, on the 2nd day after the operation, on the 7th day, 14th day, and 30th day after the operation.
Measured: Preoperative and postoperative 2nd, 7th, 14th and 30th days
VAS Pain Scor
The VAS scale was used to assess the pain of the patients. Patients were instructed on how and at what time to fill out the scale, and were asked to fill out the scores from 0 to 10 (0, no pain; 10, unbearable pain) at hours 3, 6, 9, 12, and 24 and days 2, 3, 4, 5, 6, 7, 14, and 30. In order to assess the analgesic use of the patients, they were asked to note their additional analgesic use on the forms given to them.
Measured: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
Analgesic Consumption
In order to evaluate the patients' analgesic use, patients were asked to note their additional analgesic use on the forms given to them.
Measured: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start4 Oct 2021
- Primary completion15 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Wisdom Tooth RemovalStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823934
- Sponsor's protocol ID
- YYU-13/20.09.2021
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayer A, Wijaya B, Mobus L, Rademacher F, Rodewald M, Tohidnezhad M, Pufe T, Drucke D, Glaser R, Harder J. Platelet-Released Growth Factors and Platelet-Rich Fibrin Induce Expression of Factors Involved in Extracellular Matrix Organization in Human Keratinocytes. Int J Mol Sci. 2020 Jun 20;21(12):4404. doi: 10.3390/ijms21124404.
PubMed 32575800Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021.
PubMed 33778163Selvido DI, Bhattarai BP, Niyomtham N, Riddhabhaya A, Vongsawan K, Pairuchvej V, Wongsirichat N. Review of dexamethasone administration for management of complications in postoperative third molar surgery. J Korean Assoc Oral Maxillofac Surg. 2021 Oct 31;47(5):341-350. doi: 10.5125/jkaoms.2021.47.5.341.
PubMed 34713808Moore RA, Derry S, Wiffen PJ, Straube S, Aldington DJ. Overview review: Comparative efficacy of oral ibuprofen and paracetamol (acetaminophen) across acute and chronic pain conditions. Eur J Pain. 2015 Oct;19(9):1213-23. doi: 10.1002/ejp.649. Epub 2014 Dec 22.
PubMed 25530283Bailey E, Worthington HV, van Wijk A, Yates JM, Coulthard P, Afzal Z. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth. Cochrane Database Syst Rev. 2013 Dec 12;2013(12):CD004624. doi: 10.1002/14651858.CD004624.pub2.
PubMed 24338830Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
PubMed 32712962Elbahisi YHM, Keskin Tunc S, Baskan Onal A, Baydar S. Evaluation of the effects of A-PRF and oral dexamethasone use on postoperative complications in third molar extraction: a split-mouth randomized-controlled trial. BMC Oral Health. 2026 Jul 9. doi: 10.1186/s12903-026-09135-3. Online ahead of print.
PubMed 42421033
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of A-Prf and Oral Dexamethasone Use on Postoperative Complications in Third Molar Tooth Extraction
- ClinicalTrials.gov ID
- NCT06823934
- Acronym / sponsor ID
- YYU-13/20.09.2021
- Conditions
- Wisdom Tooth Removal
- Keywords
- Third Molar A-PRF, Dexamethasone, Postoperative Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 12 Feb 2025 (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.
Impacted third molar tooth extraction is one of the most frequently performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the patient's quality of life in the postoperative period. Today, there are many methods used to prevent or treat these complications. Corticosteroid use and A-PRF biomaterial obtained from the patient's own blood are some of these methods. In patients with bilaterally impacted lower wisdom teeth, A-PRF was applied to one side after extraction and postoperative oral dexamethasone was used to the other side. Intra-group and inter-group evaluations were made by collecting the patients' pain, edema, trismus and analgesic use data.
Detailed description
Impacted third molar tooth extraction is one of the most commonly performed procedures in oral surgery. Complications such as pain, swelling and trismus, which are frequently seen after this operation, affect the quality of life of the patient in the postoperative period and may cause patients to avoid this procedure. Today, there are many methods used to prevent or treat these complications. The use of corticosteroids and the A-PRF biomaterial obtained from the patient's own blood are some of these methods. No study has been found in the literature comparing the effects of oral use of dexamethasone, a corticosteroid drug, with A-PRF on pain, edema, trismus and analgesic use. In patients with bilateral impacted lower wisdom teeth, A-PRF was applied to the extraction site after extraction on one side and postoperative oral dexamethasone was used on the other side. Pain, edema, trismus and analgesic use data of the patients were collected and in-group and intergroup evaluations were made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Dexamethasone | Active comparator | Procedure: Impacted lower wisdom tooth extractionAfter the extraction of the impacted wisdom tooth, the patient was prescribed oral dexamethasone (Dekort 4mg tablet, S:3*1 DEVA brand) for 3 days. |
| A-Prf | Active comparator | Procedure: Impacted lower wisdom tooth extractionA-PRF was placed in the patients' tooth extraction sockets and the flap was closed primarily using 3/0 silk sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not having any systemic disease,
- Being over 18 years of age,
- Bilateral teeth being in similar positions and being completely impacted,
- Not having any allergies to the drugs to be used in the study.
Key exclusion criteria (5 listed)
- Infection in the area where the extraction will be performed,
- Pregnancy or breastfeeding,
- Using medication up to 2 weeks before tooth extraction,
- Not using prescribed medications regularly,
- Not coming to regular check-ups.
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 |
|---|---|---|
| Impacted lower wisdom tooth extractionOne of the most common operations performed in oral surgery is the extraction of lower impacted wisdom teeth. The extraction of impacted third molars causes significant inflammatory changes resulting in edema, trismus and pain. Complications encountered after the extraction of lower impacted wisdom teeth can negatively affect the daily lives of patients. Some of the treatments applied for these complications can be listed as drug use, cold/hot compression, low-dose laser therapy, cryotherapy, autogenous biomaterials such as PRF. | Procedure or surgery | A-Prf, Oral Dexamethasone |
Primary outcome
Maximum Mouth Opening
Time frame: Preoperative and postoperative 2nd, 7th, 14th and 30th days
For the evaluation of the maximum mouth opening of the patients, the maximum mouth opening and the distance between the incisal edges of the central teeth in the most open position of the mouth were measured before the operation, on the 2nd day after the operation, on the 7th day, 14th day and 30th day after the operation.
Edema
Time frame: Preoperative and postoperative 2nd, 7th, 14th and 30th days
For the evaluation of edema of the patients, face measurements between angulus-tragus, angulus-lateral canthus, angulus-nasal wing, angulus-labial commissure, and angulus-pogonion were made before the operation, on the 2nd day after the operation, on the 7th day, 14th day, and 30th day after the operation.
VAS Pain Scor
Time frame: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
The VAS scale was used to assess the pain of the patients. Patients were instructed on how and at what time to fill out the scale, and were asked to fill out the scores from 0 to 10 (0, no pain; 10, unbearable pain) at hours 3, 6, 9, 12, and 24 and days 2, 3, 4, 5, 6, 7, 14, and 30. In order to assess the analgesic use of the patients, they were asked to note their additional analgesic use on the forms given to them.
Analgesic Consumption
Time frame: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
In order to evaluate the patients' analgesic use, patients were asked to note their additional analgesic use on the forms given to them.
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 12 Feb 2025.
- Background: PubMed 32575800Bayer A, Wijaya B, Mobus L, Rademacher F, Rodewald M, Tohidnezhad M, Pufe T, Drucke D, Glaser R, Harder J. Platelet-Released Growth Factors and Platelet-Rich Fibrin Induce Expression of Factors Involved in Extracellular Matrix Organization in Human Keratinocytes. Int J Mol Sci. 2020 Jun 20;21(12):4404. doi: 10.3390/ijms21124404.
- Background: PubMed 33778163Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021.
- Background: PubMed 34713808Selvido DI, Bhattarai BP, Niyomtham N, Riddhabhaya A, Vongsawan K, Pairuchvej V, Wongsirichat N. Review of dexamethasone administration for management of complications in postoperative third molar surgery. J Korean Assoc Oral Maxillofac Surg. 2021 Oct 31;47(5):341-350. doi: 10.5125/jkaoms.2021.47.5.341.
- Background: PubMed 25530283Moore RA, Derry S, Wiffen PJ, Straube S, Aldington DJ. Overview review: Comparative efficacy of oral ibuprofen and paracetamol (acetaminophen) across acute and chronic pain conditions. Eur J Pain. 2015 Oct;19(9):1213-23. doi: 10.1002/ejp.649. Epub 2014 Dec 22.
- Background: PubMed 24338830Bailey E, Worthington HV, van Wijk A, Yates JM, Coulthard P, Afzal Z. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth. Cochrane Database Syst Rev. 2013 Dec 12;2013(12):CD004624. doi: 10.1002/14651858.CD004624.pub2.
- Background: PubMed 32712962Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
- Derived from this study: PubMed 42421033Elbahisi YHM, Keskin Tunc S, Baskan Onal A, Baydar S. Evaluation of the effects of A-PRF and oral dexamethasone use on postoperative complications in third molar extraction: a split-mouth randomized-controlled trial. BMC Oral Health. 2026 Jul 9. doi: 10.1186/s12903-026-09135-3. Online ahead of print.
- 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 Impacted lower wisdom tooth extraction in people with Wisdom Tooth Removal, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 12 Feb 2025. 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 Turkey (Türkiye). 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. 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?
Maximum Mouth Opening (time frame: Preoperative and postoperative 2nd, 7th, 14th and 30th days). The study lists 4 primary outcomes in all. 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 NCT06823934, which also lists 7 linked publications.
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 12 Feb 2025.