Clinical trial NCT03578549: Diagnostic Device for the Assessment of Pulpal Blood Flow
Official title: Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Pulp Test
Keywords: Dental Pulp Test
Vitality Testing
Pulpal Blood Flow Measure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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

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.

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

Primary outcomes:
measure: Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp
timeFrame: Single visit, less than one hour testing
Secondary outcomes:
measure: Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth
timeFrame: Single visit, less than one hour testing
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Darya Dabiri, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: