Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318013
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-03-12
Brief Title:
Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints
Sponsor:
Karamanoğlu Mehmetbey University
Organization:
Karamanoğlu Mehmetbey University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None