Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
2013年7月6日 更新者:Mohammad Javad Shirani
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.
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
75
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Isfahan、伊朗伊斯兰共和国、81745-319
- 招聘中
- Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
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接触:
- Mohammadjavad Shirani, Dr
- 电话号码:00989356039479
- 邮箱:javaad.sh_f@yahoo.com
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首席研究员:
- Mohammadjavad Shirani, Dr
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
-Unwilling participants to continue the study and those with abnormality of wound healing process
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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
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single dose of dexamethasone (8mg) will injected
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有源比较器: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
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single dose of dexamethasone (8mg) will injected
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Pain
大体时间:48 hours and one week after intervention
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Visual analogue scale of pain- Number of required analgesics tablets
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48 hours and one week after intervention
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Changes in Swelling
大体时间:48 hours and one week after intervention
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Questionnaire and VAS
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48 hours and one week after intervention
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Changes in Trismus
大体时间:48 hours and one week after intervention
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Questionnaire
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48 hours and one week after intervention
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Changes in General patients' satisfaction
大体时间:48 hours and one week after intervention
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Visual analogue scale for satisfaction
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48 hours and one week after intervention
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Changes in Quality of life
大体时间:96 hours and one week after intervention
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Questionnaire
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96 hours and one week after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Trismus
大体时间:one week period after the surgery
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Questionnaire about Maximum mouth opening- Patients complaint
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one week period after the surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Bijan Movahedian, Oral and maxillofacial surgeon、Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (预期的)
2014年4月1日
研究注册日期
首次提交
2013年6月30日
首先提交符合 QC 标准的
2013年7月6日
首次发布 (估计)
2013年7月11日
研究记录更新
最后更新发布 (估计)
2013年7月11日
上次提交的符合 QC 标准的更新
2013年7月6日
最后验证
2013年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.