An observational study in Dental Pulp Test, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by University of Michigan · Observational
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.
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.
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
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30 healthy individuals with 2-5 non-endodonticaly treated teeth in addition to the tooth planned for the extraction with intact non-metallic crown
In order to be eligible to participate in this study, you must meet the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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.
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
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
| Milestone | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
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.
| Teeth | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Normal Pulp | 111 |
| Abnormal Pulp | 32 |
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).
| Percentage of saturation | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth | 87.9 ± 11.8 |
Collected over Through study completion an average of one day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oximetry Testing of Healthy Teeth and Those Requiring Removal | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 0 |
| Age, Continuous(years) | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Mean | 32.7 ± 13.35 |
| Sex: Female, Male(Participants) | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| Female | 20 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 29 |
| Region of Enrollment(participants) | Oximetry Testing of Healthy Teeth and Those Requiring Removal |
|---|---|
| United States | 29 |
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