NCT06823934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Wisdom Tooth Removal

Keywords

Third Molar A-PRFDexamethasonePostoperative Complication

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Post-operative 3, 6, 9, 12, 24 hours and 2, 3, 4, 5, 6, 7, 14 and 30 days

Study Arms (2)

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.

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.

Procedure: Impacted lower wisdom tooth extraction

Interventions

Impacted lower wisdom tooth extractionPROCEDURE

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-PrfOral Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 65080, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 32575800BACKGROUND

  • 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.

    PMID: 33778163BACKGROUND

  • 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.

    PMID: 34713808BACKGROUND

  • 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.

    PMID: 25530283BACKGROUND

  • 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.

    PMID: 24338830BACKGROUND

  • 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.

    PMID: 32712962BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 12, 2025

Study Start

October 4, 2021

Primary Completion

August 15, 2022

Study Completion

September 15, 2022

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)