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临床试验/NCT01896427
NCT01896427Unknown4 期

Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods

Mohammad Javad Shirani1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

发起方
Mohammad Javad Shirani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad Javad Shirani

Dr

Isfahan University of Medical Sciences

研究点 (1)

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