Diagnostic Device for the Assessment of Pulpal Blood Flow

Completed

• Conditions: Dental Pulp Test
• Interventions: Device: Pulse Oximetry

• Registration Number: NCT03578549
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Study Start: 2018-07-12
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2020-08-12
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-20
• Last Update Submitted: 2020-09-20
• Results First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, you must meet the following criteria:

1. Must be a patient of the Oral Surgery Clinic at the University of Michigan School of Dentistry
2. Must be scheduled for at least one tooth extraction at Oral Surgery Clinic
3. Must be able to understand and willing to cooperate with all study procedures
4. Must be able to sign an IRB-approved written consent
5. Must have at least two teeth with an intact crown, without any full metallic crown coverage, and/or previous root canal treatments
6. 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.
7. 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"

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oximetry testing of healthy teeth and those requiring removal	Pulse Oximetry	To assess the ability of pulse oximeter to assess the presence of pulse in teeth and to correlate pulse oximeter readings with conventional pulp testing measures including cold test, electrical pulp test, percussion and palpation testings, pulse oximeter will be used with a special holding frame, for 15-30 seconds. Note: the reading will not affect clinical practice; it is simply to gather data to see if pulse oximetry can facilitate diagnostic practices in the future

Primary Outcome Measures

Name	Time	Method
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp	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.

Secondary Outcome Measures

Name	Time	Method
Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth	Single visit, less than one hour testing	Objective plural blood flow measurements will be used for teeth that are planned for extraction and also up to 2-5 additional teeth in each participant. Average objective plural blood flow was determined by pulse oximetry-reading for selected teeth (measured as SpO2).

Trial Locations

Locations (1)

Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States