- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06823934
Evaluation of the Effects of A-Prf and Oral Dexamethasone Use in Third Molar Extraction
February 6, 2025 updated by: Serap Keskin Tunc, Yuzuncu Yıl University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Van, Turkey, 65080
- Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Oral Dexamethasone
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.
|
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.
|
|
Active Comparator: A-Prf
A-PRF was placed in the patients' tooth extraction sockets and the flap was closed primarily using 3/0 silk sutures.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative and postoperative 2nd, 7th, 14th and 30th days
|
|
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.
|
Preoperative and postoperative 2nd, 7th, 14th and 30th days
|
|
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.
|
Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
|
|
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.
|
Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Pavlovic 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.
- Selvido 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.
- Moore 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.
- Bailey 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.
- Bailey 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2021
Primary Completion (Actual)
August 15, 2022
Study Completion (Actual)
September 15, 2022
Study Registration Dates
First Submitted
February 6, 2025
First Submitted That Met QC Criteria
February 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 6, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYU-13/20.09.2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wisdom Tooth Removal
-
Universidad Complutense de MadridNot yet recruitingTooth Extraction | Periodontal Regeneration | Wisdom Tooth Removal
-
Sana'a UniversityEnrolling by invitationMethylprednisolone | Hyaluronic Acid | Post Operative Complications | Wisdom Tooth RemovalYemen
-
Saglik Bilimleri UniversitesiCompletedWound Healing | Magnesium Level | Wisdom Tooth RemovalTurkey (Türkiye)
-
Sigmund Freud PrivatUniversitatNot yet recruitingHeart Rate | Fear Anxiety | Wisdom Tooth RemovalAustria
-
National Taiwan University HospitalEnrolling by invitationEfficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower JawsDental Impaction | Wisdom ToothTaiwan
-
Ceren Melahat DonmezerCompletedImpacted Wisdom ToothCyprus
-
Tufts University School of Dental MedicineUnknownImpacted Wisdom TeethUnited States
-
Kutahya Health Sciences UniversityActive, not recruiting
-
Haifaa Mohammed Al-hussiniActive, not recruitingAlveolar Bone Grafting | Bone Regeneration Following Wisdom Teeth Extraction | Tooth Extraction Site HealingYemen
-
Franciscan University CenterCompletedGingival Abrasion | Biofilm RemovalBrazil
Clinical Trials on Impacted lower wisdom tooth extraction
-
Yuzuncu Yıl UniversityCompletedImpacted Mandibular Third Molar ExtractionTurkey
-
Medical University of SilesiaCompletedImpacted Third Molar ToothPoland
-
National Institute of Nursing Research (NINR)Completed
-
Kutahya Health Sciences UniversityCompletedDental Anxiety | Virtual Reality | Impact MolarTurkey (Türkiye)
-
University of PisaRecruitingProbiotics | Wound Heal | Tooth, Impacted | Gastrointestinal ComplicationItaly
-
Professor David BearnNHS TaysideTerminatedPaediatric DentistryUnited Kingdom
-
University of BaghdadRecruitingImpacted Third Molar ToothIraq
-
Yuzuncu Yıl UniversityCompletedTooth Diseases | Tooth, ImpactedTurkey
-
Yuzuncu Yıl UniversityCompletedTooth Diseases | Tooth ImpactionTurkey