NCT06318013

Brief Summary

Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

19 days

First QC Date

March 12, 2024

Last Update Submit

May 29, 2024

Conditions

Keywords

Impacted third molarDexamethasoneanesthesia duration

Outcome Measures

Primary Outcomes (2)

  • Swelling

    In order to determine the course of postoperative edema in patients with tooth extraction, tragus-pogonion (S1), tragus-mouth canthus (S2) and gonion-lateral canthus (S3) will be measured with the help of a tape measure.

    1 week

  • Duration of anesthesia

    After anesthesia, the time it takes for numbness to subside will be measured in minutes. A vitalometer device will be used to check that anesthesia has passed.

    6 hours

Secondary Outcomes (1)

  • Pain Score

    1 week

Study Arms (3)

Control

Group receiving only local anesthesia

Diagnostic Test: vitality test

Intravenous Dexamethasone

Group using dexamethasone IV

Diagnostic Test: vitality test

Perineural Dexamethasone

group administered perineural dexamethasone

Diagnostic Test: vitality test

Interventions

vitality testDIAGNOSTIC_TEST

A vitality test will be performed using a vitalometer to check if the drowsiness is gone

ControlIntravenous DexamethasonePerineural Dexamethasone

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, male and female patients between the ages of 18-35

You may qualify if:

  • ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, with no signs of inflammation and no dental pathology

You may not qualify if:

  • Pregnant or breastfeeding women, patients with diabetes, endocrine disease, hypertension patients, patients with bleeding disorders or using anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry

Karaman, 70100, Turkey (Türkiye)

Location

Related Publications (4)

  • Ruthvik S, Krishnan M, George M, Kumar SP, Lakshmanan S. Efficacy of Dexamethasone Diluted Saline Irrigant on Postoperative Sequelae in Patients Undergoing Lower Third Molar Surgery: A Prospective Clinical Study. Cureus. 2023 Sep 18;15(9):e45436. doi: 10.7759/cureus.45436. eCollection 2023 Sep.

  • Poorna P, Shetty P, Kalyani V, Shetty S, Upadya M, Mithra P. A comparative evaluation of the effect of addition of 8 mg dexamethasone to 2% lignocaine with adrenaline in mandibular third molar surgery: a split mouth randomised double blind study. Front Oral Health. 2024 Feb 9;5:1349832. doi: 10.3389/froh.2024.1349832. eCollection 2024.

  • Priyanga R, Balamurugan R, Rajan PS. Comparison of dexamethasone administration through sublingual and intramuscular routes for evaluation of pain, swelling, and trismus after impacted mandibular third molar surgery-a prospective randomized controlled study. Oral Maxillofac Surg. 2022 Mar;26(1):155-159. doi: 10.1007/s10006-021-00978-4. Epub 2021 Jun 5.

  • Kaya DI, Akti A. Comparison of perineural and systemic dexamethasone use in impacted third molar surgeries in terms of anesthesia duration and postoperative complaints: a controlled, randomized observational study. BMC Oral Health. 2024 Jun 18;24(1):706. doi: 10.1186/s12903-024-04483-4.

Study Officials

  • Ahmet Aktı, Dr

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

March 27, 2024

Primary Completion

April 15, 2024

Study Completion

May 26, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

We do not need to record participants' personal data for this study.

Locations