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Trial record 54 of 621 for:    oximeter

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
Sponsor:
Information provided by (Responsible Party):
Darya Dabiri, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Dental Pulp Test Device: Pulse Oximetry Not Applicable

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.

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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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Darya Dabiri, DMD, MS 734-998-6983 daryad@umich.edu
Contact: Kathy Scott 734-998-7022 jrsj@med.umich.edu

Locations
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United States, Michigan
Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Darya Dabiri         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Darya Dabiri, DMD, MS University of Michigan

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Responsible Party: Darya Dabiri, Post Doc Research Fellow, Faculty of Anesthesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT03578549     History of Changes
Other Study ID Numbers: HUM00136199
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Darya Dabiri, University of Michigan:
Dental Pulp Test
Vitality Testing
Pulpal Blood Flow Measure