Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intra-operative pain during extraction
研究概览
简要总结
The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.
详细描述
To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.
This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit (ASA I, II).
- •Mentally capable of communication.
- •Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
- •First maxillary primary molar needs extraction due to root caries "beyond possible repair".
- •First dental visit.
- •Child must give assent prior to participation, as well as approved parental informed written consent.
排除标准
- •Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
- •Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
结局指标
主要结局
Intra-operative pain during extraction
时间窗: through study completion, an average of 1 year
measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale
次要结局
- onset of anesthesia(through study completion, an average of 1 year)
- duration of anesthesia(through study completion, an average of 1 year)
研究者
Ghada Mohamed Mostafa Mahmoud
Dr
Cairo University