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临床试验/NCT03005197
NCT03005197Unknown不适用

A Prospective Study to Assess the Diagnostic Accuracy of Laser Doppler Flowmetry in Assessing Pulp Vitality of Traumatised Teeth in Paediatric Patients

University of Leeds0 个研究点目标入组 30 人开始时间: 2017年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Sensitivity

研究概览

简要总结

Teeth injuries are considered one of the most challenging events that occur in dentistry, especially in children. After an injury, there is a possibility that the blood supply to the tooth may become affected and compromised leading to nerve and blood vessels death with the tooth described as a non-vital tooth.

The conventional diagnostic tools available to assess tooth nerve/blood supply are not always reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or de-vitalising a normal tooth which may render the tooth weak for the future and possibly losing the tooth.

The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more reliable than the traditional techniques. We aim to assess if this device can predict and assess whether the tooth is alive or dead during the follow up visits of the injury along the other conventional tests.

详细描述

A clinical study will be carried out which consists of a one year follow up to monitoring traumatised front teeth in children attending the department of paediatric dentistry.

The vitality/sensibility of traumatised teeth will be assessed using laser Doppler flowmetry, electrical pulp testing and ethyl chloride. Measurements will be performed by a single operator (chief investigator) and will be carried out at baseline, 3, 6, 9 and 12 months follow up period.

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
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Medically and mentally compromised children.
  • Children with learning disabilities.
  • Children with communication barrier including those unable to communicate using English language.
  • Heavily restored teeth covering more than half the labial surface of teeth.
  • Patients on routine analgesics, antidepressants or antihypertensive drugs.
  • Vital teeth with pulp canal obliteration.

结局指标

主要结局

Sensitivity

时间窗: One year follow up

Specificity

时间窗: One year follow up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahar Ghouth

Principal Investogator

University of Leeds

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