NCT01073371已完成1 期
Local Anesthetics New Formulations: From Development to Clinical Tests
University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Anesthesia success, onset and duration of pulpal and gingival anesthesia.
研究概览
简要总结
This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •good health
- •no history of allergy to the components of the local anesthetic formulations tested
- •maxillary canine, lateral incisor, and first premolar responsible to electric stimulation
排除标准
- •intake of any medication that would alter pain perception
- •history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
- •systemic disease
研究组 & 干预措施
liposome-encapsulated 3% prilocaine
Active Comparator
干预措施: Prilocaine (Drug)
3% plain prilocaine
Active Comparator
干预措施: Prilocaine (Drug)
3% prilocaine with 0,03IU/mL felypressin
Active Comparator
干预措施: Prilocaine (Drug)
结局指标
主要结局
Anesthesia success, onset and duration of pulpal and gingival anesthesia.
时间窗: 10 minutes
次要结局
- Injection pain - Visual Analogue Scale(1 minute after the injections)
研究者
研究点 (1)
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