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临床试验/NCT01593930
NCT01593930已完成不适用

Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block

Zahedan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年5月1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
Success rate

研究概览

简要总结

The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).

详细描述

According to inclusion & exclusion criteria, volunteers will be selected and divided into 4 groups randomly. The clinician who does the injections will not be aware of study purpose. Also the person who does the electric pulp test (EPT); the volunteer and the statistical analyzer will not be aware of group codes. Intervention in each group will be as follow: Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group 3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4- Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine. Before injection a control tooth (contralateral canine) will be tested to understand the accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth will be evaluated by EPT twice before injection. After injection each tooth will be evaluated by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked, up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in addition to the success rate the mean time for onset of anesthesia and its mean duration time will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with at least 1 vital first mandibular molar without any restoration or decay

排除标准

  • Patients with systemic conditions which eliminate the use of epinephrine
  • Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
  • Pregnant women
  • Use of analgesics, opioids or any other drugs which influence the anesthesia

结局指标

主要结局

Success rate

时间窗: Every 3 minutes after injection

Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.

次要结局

  • Onset of anesthesia(Every 3 minutes after injection)
  • Duration of anesthesia(Every 3 minutes after onset of anesthesia)

研究者

发起方
Zahedan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaveh Oloomi, DDS, MS

Assistant Professor

Zahedan University of Medical Sciences

研究点 (1)

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