Clinical trial NCT06318013: Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Third Molar Tooth
Keywords: Impacted third molar
Dexamethasone
anesthesia duration
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, male and female patients between the ages of 18-35

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Swelling
timeFrame: 1 week
measure: Duration of anesthesia
timeFrame: 6 hours
Secondary outcomes:
measure: Pain Score
timeFrame: 1 week
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry
Study officials:
affiliation: Selçuk University
name: Ahmet Aktı, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.