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临床试验/CTRI/2024/07/070692
CTRI/2024/07/070692尚未招募不适用

Assessment of Intraoperative characteristics of dental pulp in carious primary teeth with pulpitis

Dr Komal Yadav1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
282
试验地点
1
主要终点
We will be assessing the colour of pulpal bleed and the duration within which pulpal bleeding stops as the intraoperative characteristics of pulp in the carious teeth affected by pulpitis

研究概览

简要总结

The diagnosis based on history, clinical examination, and radiographic assessment has limitations especially in the pediatric population as it relies on the patient’s response (pain, sensitivity) and radiographs, which offer limited information about the pulp’s health itself. Pain perception is considered subjective and varies between individuals and is less reliable in children. Further, the percussion and sensibility tests depend on the patient’s interpretation, leading to potential inaccuracies. To sum up, there is insufficient evidence to determine whether the presence, nature, and duration of toothache offer accurate information about the extent to which dental pulp is inflamed. Therefore, this cross-sectional study will assess the intraoperative findings of dental pulp in carious primary teeth with pulpitis. These intraoperative findings will further help to serve as a standard to decide regarding the type of treatment that needs to be rendered in carious teeth with pulpitis. Simultaneously, an association can be drawn depending upon study results between the intraoperative dental findings and their preoperative diagnosis.

研究设计

研究类型
Interventional
分配方式
Na
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

  • (1) Age group 4 to 9 years.
  • (2) Primary maxillary/mandibular posterior tooth with deep occlusal and/or proximal caries exhibiting the signs of pulpitis i.e. sensitivity and/or pain and/or pulp exposure which is clinically evident [International Caries Detection and Assessment System Score 4, 5, and 6].
  • (3) Children with Frankl’s behavior rating of 3 and 4.

排除标准

  • (1) Teeth with gingival abscess and/or extraoral swelling/sinus formation/pathological mobility (2) Patients with systemic disorders and/or a history of long-term medications that can influence the diagnosis.
  • (3) Frankl’s behavior rating of 1 and 2 [uncooperative children].

结局指标

主要结局

We will be assessing the colour of pulpal bleed and the duration within which pulpal bleeding stops as the intraoperative characteristics of pulp in the carious teeth affected by pulpitis

时间窗: At Baseline

次要结局

未报告次要终点

研究者

发起方
Dr Komal Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Komal Yadav

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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