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临床试验/NCT05475795
NCT05475795Unknown不适用

Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial

Minia University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
postoperative pain.

研究概览

简要总结

Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

详细描述

The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

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
Double (Participant, 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

入选标准

  • Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:
  • 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
  • Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
  • Presence of at least one primary molar with deep carious lesion.
  • Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.
  • Radiographic:
  • Extensive caries approaching to the pulp.
  • Presence of at least two-thirds of root length.

排除标准

  • A child's tooth with any of the following criteria:
  • Clinical findings:
  • History of spontaneous unprovoked toothache.
  • Extensive crown destruction that preclude coronal restoration.
  • Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
  • History of administering analgesics 12 hours before tooth obturation.
  • Radiographic findings:
  • Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
  • Presence of pathological internal/external root resorption.
  • Absence of underlying permanent successor.

结局指标

主要结局

postoperative pain.

时间窗: after one day and after one week .

Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).

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

Nada Mohamed Hassan

Postgraduate student at Faculty of Dentistry Minia University

Minia University

研究点 (2)

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