Clinical trial NCT06823934: Evaluation of the Effects of A-Prf and Oral Dexamethasone Use in Third Molar Extraction
Official title: Evaluation of the Effects of A-Prf and Oral Dexamethasone Use on Postoperative Complications in Third Molar Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wisdom Tooth Removal
Keywords: Third Molar A-PRF
Dexamethasone
Postoperative Complication
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Mouth Opening
timeFrame: Preoperative and postoperative 2nd, 7th, 14th and 30th days
measure: Edema
timeFrame: Preoperative and postoperative 2nd, 7th, 14th and 30th days
measure: VAS Pain Scor
timeFrame: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
measure: Analgesic Consumption
timeFrame: Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.