Diagnostic Device for the Assessment of Pulpal Blood Flow

NCT ID: NCT03578549

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-06-30

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.

Conditions

Dental Pulp Test

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Oximetry testing of healthy teeth and those requiring removal

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

Pulse Oximetry

Intervention Type: 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.

Interventions

Pulse Oximetry

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.

Intervention Type: DEVICE

Eligibility Criteria

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"

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Darya Dabiri

Post Doc Research Fellow, Faculty of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darya Dabiri, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00136199

Identifier Type: -

Identifier Source: org_study_id