Dental Pulp Test
Conditions
Keywords
Dental Pulp Test, Vitality Testing, Pulpal Blood Flow Measure
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.
Interventions
DEVICEPulse 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.
Sponsors
University of Michigan
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 13.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
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.
Time frame: Single visit, less than one hour testing
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Oximetry Testing of Healthy Teeth and Those Requiring Removal | Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp | Normal Pulp | 111 Teeth |
| Oximetry Testing of Healthy Teeth and Those Requiring Removal | Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp | Abnormal Pulp | 32 Teeth |
Secondary
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).
Time frame: Single visit, less than one hour testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oximetry Testing of Healthy Teeth and Those Requiring Removal | Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth | 87.9 Percentage of saturation | Standard Deviation 11.8 |
p-value: 0.92ANOVA