Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Face, Legs, Activity, Cry, Consolability pain scale
研究概览
简要总结
A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.
The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
- •Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
- •Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis
排除标准
- •Molars with unrestorable crowns
- •Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
结局指标
主要结局
Face, Legs, Activity, Cry, Consolability pain scale
时间窗: up to 24 hours
its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10
次要结局
未报告次要终点
研究者
Ahmad Elheeny
Assistant Professor
Minia University