Evaluation of the Effects of A-Prf and Oral Dexamethasone Use in Third Molar Extraction

NCT ID: NCT06823934

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-09-15

Brief Summary

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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

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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

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Wisdom Tooth Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Impacted lower wisdom tooth extraction

Intervention Type PROCEDURE

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.

A-Prf

A-PRF was placed in the patients' tooth extraction sockets and the flap was closed primarily using 3/0 silk sutures.

Group Type ACTIVE_COMPARATOR

Impacted lower wisdom tooth extraction

Intervention Type PROCEDURE

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.

Interventions

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Impacted lower wisdom tooth extraction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Serap Keskin Tunc

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32575800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33778163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34713808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25530283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24338830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32712962 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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YYU-13/20.09.2021

Identifier Type: -

Identifier Source: org_study_id

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