Diagnostic Device for the Assessment of Pulpal Blood Flow
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|ClinicalTrials.gov Identifier: NCT03578549|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dental Pulp Test||Device: Pulse Oximetry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Oximetry Testing of Teeth Scheduled to be Extracted and Others|
|Masking:||None (Open Label)|
|Official Title:||Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: 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.
- Correlation Between Subjective and Objective Measurements of Pulpal Status [ Time Frame: Single visit, less than one hour testing ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578549
|Contact: Darya Dabiri, DMD, MSfirstname.lastname@example.org|
|Contact: Kathy Scottemail@example.com|
|United States, Michigan|
|Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: Darya Dabiri|
|Principal Investigator:||Darya Dabiri, DMD, MS||University of Michigan|