CTRI/2025/07/090744尚未招募Phase 3 4
Effectiveness of Combined Extraoral Vibration and Cooling on Pain Perception during IANB administration in Children: a split mouth randomised controlled trial
Harsh Baldawa1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月22日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- pain perception that is subjective and objective pain
研究概览
简要总结
This study investigated the effectiveness of a novel EVC device in reducing pain perception and physiological stress during IANB administration in children. Pain and anxiety are significant concerns in pediatric dentistry, often impacting cooperation and long-term dental attitudes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged four to nine years Requiring bilateral LA for dental procedures such as pulp therapy, extraction, or restorative treatment Medically healthy children with no systemic conditions affecting pain perception Cooperative behavior rated as three or four on the Frankl Behavior Rating Scale.
排除标准
- •Neurological or cognitive impairments History of adverse reactions to local anesthetics Presence of intraoral soft tissue lesions or infections at the injection site Use of analgesics or sedatives within 24 hours prior to the procedure.
结局指标
主要结局
pain perception that is subjective and objective pain
时间窗: baseline - while local anesthesia administration
次要结局
- Anxiety(baseline - during administration of local anesthesia)
研究者
Harsh Sanjaykumar Baldawa
Saveetha Dental College and Hospital
研究点 (1)
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