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临床试验/NCT05267847
NCT05267847Unknown不适用

The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible

Minia University2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2022年2月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
188
试验地点
2
主要终点
Pain assessment

研究概览

简要总结

The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children are classified as I or II according to ASA
  • Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
  • Presence of at least two-thirds of the root length in periapical radiograph

排除标准

  • Unrestorable crowns
  • Children with systemic, severe behavior or emotional problems
  • Presence of gingival redness, swellings, fistulous of sinus tract
  • Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency

结局指标

主要结局

Pain assessment

时间窗: up to 24 hours

Wong Backer pain scale

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Elheeny

Assistant Professor

Minia University

研究点 (2)

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