CTRI/2025/03/081998尚未招募2 期
A Comparative evaluation of four differentIntrapulpal agents in Pulpectomy Procedures for reducing pain and anxiety in Children with Symptomatic Irreversible Pulpitis
Chettinad Dental College and Research Institute1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年3月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- heart rate—physiological reading to assess anxiety of the children before, during and after administration of intrapulpal anesthesia
研究概览
简要总结
This study is a randomized, parallel-group, single-center trial comparing the effectiveness of different intrapulpal techniquesin reducing pain and anxiety for 3 months in 76 children that will be conducted in India. The primary outcomemeasures will be heart rate measured before, during, and after administration ofintrapulpal anesthesia. The secondary outcomes will be WBFPS and FLACC scales measuredbefore, during and after administration of intrapulpal anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Day(s) 至 8.00 Day(s)（—）
- 性别
- All
入选标准
- •Healthy children ASA 1 Primary mandibular molar requiring supplemental anesthesia for pulpectomy Depicting normal apical tissue radiographically.
- •Child who will demonstrate appropriate understanding of the pain scale.
排除标准
- •Children who are allergic to amides are suffering from any systemic diseases.
- •Children with a previous history of bad dental experience.
- •Primary mandibular molar with pulpal necrosis Depicting radiolucency in apical region, radiographically.
结局指标
主要结局
heart rate—physiological reading to assess anxiety of the children before, during and after administration of intrapulpal anesthesia
时间窗: before, during and after administration of intrapulpal anesthesia
次要结局
- wong bakers faces pain scale to assess pain before, during & after administration of intrapulpal anesthesia(before during & after administration of intrapulpal anesthesia)
- FLACC scale to assess the behavior of the child before, during & after administration of intrapulpal anesthesia(before, during & after administration of intrapulpal anesthesia)
研究者
研究点 (1)
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