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临床试验/NCT06318013
NCT06318013已完成不适用

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.

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Duration of anesthesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Duration of anesthesia

时间窗: 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.

Swelling

时间窗: 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.

次要结局

  • Pain Score(1 week)

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dogan Ilgaz Kaya

Assistant Professor

Karamanoğlu Mehmetbey University

研究点 (1)

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