Diagnostic Device for the Assessment of Pulpal Blood Flow

Pulse Oximeter is a Potential 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.

Study Overview

• Status: Completed
• Conditions: Dental Pulp Test
• Intervention / Treatment: Device: Pulse Oximetry

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 healthy individuals with 2-5 non-endodonticaly treated teeth in addition to the tooth planned for the extraction with intact non-metallic crown

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp	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.	Single visit, less than one hour testing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth	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).	Single visit, less than one hour testing

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Darya Dabiri, DMD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dental Pulp Test; Vitality Testing; Pulpal Blood Flow Measure
• Other Study ID Numbers: HUM00136199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes