跳至主要内容
临床试验/NCT04607395
NCT04607395已完成不适用

Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
358
试验地点
1
主要终点
Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs

研究概览

简要总结

Preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. In clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. This lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise and is not used as a diagnostic element.

The aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pre-operative radiographs of deep carious lesions treated with DECAT protocole, unless they were out of the study.

排除标准

  • Impossibility to assess carious lesion on radiograph, and amalgam restorations that impairs correct examination of carious lesion
  • Radiographs of poor quality and screen captures

结局指标

主要结局

Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs

时间窗: Outcome measure was assessed trough study completion, an average of 1 year.

The radiographic assessment consisted in determining the depth of each carious lesion from the pre-operative radiographs and from their contrasted version. In this work, the depth of one carious lesion was measured by the ratio (expressed in percent): 100\*residual dentin thickness (RDT)/ Total dentin thickness (TDT). A logistic regression that accounted for measurement error was applied to precisely estimate the capacity of the ratio to predict exposure (reported as odds-ratio).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验