NCT01572116已完成2 期
Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis
Islamic Azad University, Tehran1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- depth of anesthesia
研究概览
简要总结
The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients in the age group of 18-65 years old
- •healthy (ASA I, II)
- •patients with first or second mandibular molars who need endodontic treatment
- •vital tooth without a history of past endodontic treatment
- •patients with clinical evidence of irreversible Pulpits with moderate to severe pain
- •patients who signed consent form
- •patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.
排除标准
- •pregnant or nursing
- •necrotic tooth
- •patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
- •Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
- •patient with infectious diseases
- •patient with moderate to sever periodontal disease
- •those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.
研究组 & 干预措施
Lidocaine with Epinephrine+ Normal saline
Placebo Comparator
干预措施: Lidocaine with Epinephrine+ Normal saline (Drug)
Lidocaine with Epinephrine + sufentanil
Active Comparator
干预措施: Lidocaine with Epinephrine + sufentanil (Drug)
结局指标
主要结局
depth of anesthesia
时间窗: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment
The measuring method of the pain is Electric pulp tester
次要结局
- intensity of the pain(before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy)
研究者
Mandana Abedi Tari
principal investigator
Islamic Azad University, Tehran
研究点 (1)
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