Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in Pain
研究概览
简要总结
In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus. In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented. These methods are reducing post operative complications to moderate level. In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study. During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded. The included participants will be assigned into three 25-people groups. The surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison was done between these three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
- •They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
- •Should not medicated by any possibly bias maker drug
- •Type of the impaction, must not provide sever difficulty
- •The participants should be mentally at healthy level and provide written informed consent to incorporate in the study
排除标准
- •Unwilling participants to continue the study and those with abnormality of wound healing process
研究组 & 干预措施
Dexamethazone IO
For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space
干预措施: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione (Drug)
Dexamethasone IM
For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space
干预措施: 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione (Drug)
结局指标
主要结局
Changes in Pain
时间窗: 48 hours and one week after intervention
Visual analogue scale of pain- Number of required analgesics tablets
Changes in Swelling
时间窗: 48 hours and one week after intervention
Questionnaire and VAS
Changes in Trismus
时间窗: 48 hours and one week after intervention
Questionnaire
Changes in General patients' satisfaction
时间窗: 48 hours and one week after intervention
Visual analogue scale for satisfaction
Changes in Quality of life
时间窗: 96 hours and one week after intervention
Questionnaire
次要结局
- Trismus(one week period after the surgery)
研究者
Mohammad Javad Shirani
Dr
Isfahan University of Medical Sciences
