Completed

NCT Number: NCT03578549

Diagnostic Device for the Assessment of Pulpal Blood Flow

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.

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Key information

Conditions

Dental Pulp Test

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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"

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

Treatment and study plan

Pulse oximetry

Device

Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional.

Primary outcomes

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

Time frame: 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 outcomes

Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 6, 2018
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.