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临床试验/NCT03578549
NCT03578549已完成不适用

Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow

University of Michigan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月12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
30
试验地点
1
主要终点
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp

研究概览

简要总结

The purpose of this study is to assess tooth health by using a pulse oximeter which measures the blood flow within the tooth. This method is not currently being used in dentistry. We hypothesize that if we can measure both sensation and blood flow in a tooth, we will be able to better determine if the tooth is "alive or dead". In the future, this method may help determine which teeth are diseased and require dental treatments.

详细描述

The vitality of the pulp is determined according to the health of the vascular supply not the sensory fibers. Conventional subjective tooth assessments (percussion, palpation, cold, and electrical pulp testing) and objective pulpal blood flow measurements will be used for teeth that are planned for extraction and also up to 2-5 additional teeth in each participant. The correlation between a single combined score from collective conventional subjective tooth assessments and the objective pulse oximetry reading for selected teeth will be used to evaluate if pulse oximeter measurements are a reliable marker for patient's reported symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In order to be eligible to participate in this study, you must meet the following criteria:
  • Must be a patient of the Oral Surgery Clinic at the University of Michigan School of Dentistry
  • Must be scheduled for at least one tooth extraction at Oral Surgery Clinic
  • Must be able to understand and willing to cooperate with all study procedures
  • Must be able to sign an IRB-approved written consent
  • Must have at least two teeth with an intact crown, without any full metallic crown coverage, and/or previous root canal treatments
  • Must have no history of spontaneous pain, and/or lingering pain to cold/hot in teeth that are not going to be extracted on that day.
  • If one of the teeth mentioned in inclusion #6 is being extracted, be willing to give your extracted tooth/teeth for further analysis to determine of the tooth is "alive or dead"

排除标准

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • If participant self-reports liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol or interpretation of the results difficult
  • If participant has severe physical impairments (e.g., complete blindness or deafness) and/or cognitive impairments (e.g., dementia) that precludes participation in the procedures outlined in this proposal
  • If participant is or could be pregnant
  • If participant is currently receiving radiation
  • If participant not able to hold mouth open for extended period of time

结局指标

主要结局

Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp

时间窗: Single visit, less than one hour testing

Conventional subjective tooth assessments (percussion, palpation, cold, and electrical pulp testing) will be used for teeth that are planned for extraction and also upto 2-5 additional teeth in each participant. Pulp status is determined as "normal" or "abnormal" according to the classification system from the American Academy of Endodontics.

次要结局

  • Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth(Single visit, less than one hour testing)

研究者

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

Darya Dabiri

Post Doc Research Fellow, Faculty of Anesthesiology

University of Michigan

研究点 (1)

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