Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints

March 27, 2024 updated by: Dogan Ilgaz Kaya, Karamanoğlu Mehmetbey University

Comparison of Perineural and Systemic Dexamethasone Use in Third Molar Dental Surgeries in Terms of Anesthesia Duration and Postoperative Complaints: a Controlled, Randomized Observational Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PURPOSE OF THE RESEARCH: Third molar tooth extraction is a frequently performed procedure in dentistry. Depending on the degree of impaction of the teeth, this procedure causes postoperative sequelae such as pain and edema that reduce the quality of life. Clinical studies have proven that the use of antibiotics, physiotherapy, corticosteroid treatment, and antiseptic mouthwashes reduce postoperative complications.

There are different ways to use costosteroids in dental practice. Intravenous, intramuscular, perineural and oral tablet administration are the most preferred. It has been proven that if dexamethasone is given systemically, the duration of anesthesia in shoulder surgeries is prolonged and post-operative pain is less. (1) However, no study evaluating this parameter regarding twenty-year-old surgeries has been found in the literature. The aim of this study is to compare the post-procedure numbness duration and postoperative sequelae in patients who were administered dexamethasone intravenously and perineurally perioperatively.

Material Method: The study is planned to be carried out at Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry. Patients who apply to the Oral and Maxillofacial Surgery Department for impacted wisdom tooth extraction and are directed to the local intervention room for tooth extraction will be asked whether they want to participate in the study after leaving the procedure room. Patients who want to participate in the study will have an informed consent form read and their signature will be taken if they declare that they want to participate in the study. Patients participating in the study will be checked for drowsiness every 30 minutes for the first 2 hours after the procedure, and every 15 minutes from the 3rd hour onwards. Drowsiness control will be done with a device called vitalometer that measures the vitality of teeth. The start time of the operation and the time the numbness subsides will be recorded. On the 1st, 3rd and 7th days following the operation, tragus-pogonion, tragus-mouth canthus and gonion-lateral canthus will be measured to evaluate swelling. Measurement will be made with a tape measure. Additionally, pain assessment and maximum mouth opening measurement will be performed with a visual analog scale on the same days. Manual caliper will be used for mouth opening measurement.

The inclusion criteria for the study were patients between the ages of 18 and 35, with ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, and without signs of inflammation and dental pathology. Pregnant or breastfeeding women, patients with diabetes, endocrine diseases, hypertension patients, bleeding disorders or patients using anticoagulants will be excluded from the study. If the duration of the surgical procedure is more than 30 minutes, if repeated doses of local anesthetic are injected during the procedure, and if surgical complications occur during the procedure, patients will be excluded from the study. This information will be checked from the epicrisis report filled out by the physician performing the operation.

Three groups will be formed by examining the procedures applied to the patients and the medications given to them from the patient follow-up program of the faculty of dentistry. It is planned to include 20 patients in each group. These are those who were administered perineural dexamethasone, those who were administered intravenous dexamethasone, and those who were not administered dexamethasone (control). The results obtained from the measurements will be compared in these 3 groups.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Karaman, Turkey, 70100
        • Recruiting
        • Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry
        • Contact:
          • Faruk Ayhan Başçiftçi, Dr
          • Phone Number: 338-226-2082
          • Email: dis@kmu.edu.tr
        • Contact:
        • Principal Investigator:
          • Doğan Ilgaz Kaya, Dr

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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Group receiving only local anesthesia
Diagnostic test: vitality test
A vitality test will be performed using a vitalometer to check if the drowsiness is gone
Intravenous Dexamethasone
Group using dexamethasone IV
Diagnostic test: vitality test
A vitality test will be performed using a vitalometer to check if the drowsiness is gone
Perineural Dexamethasone
group administered perineural dexamethasone
Diagnostic test: vitality test
A vitality test will be performed using a vitalometer to check if the drowsiness is gone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling
Time Frame: 1 week
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
Time Frame: 6 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 1 week
Vas scale (no pain:0-intolerable pain:10) will be used to measure postoperative pain in patients with tooth extraction.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karamanoğlu Mehmetbey University

Investigators

  • Principal Investigator: Ahmet Aktı, Dr, Selcuk University

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

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)

March 27, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KAEK-15427-04-204-2022101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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.

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