Dental Pulp TestNCT03578549
Diagnostic Device for the Assessment of Pulpal Blood Flow
An observational study of Dental Pulp Test, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Test
- What is being tested?
- Pulse Oximetry
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- In order to be eligible to participate in this study, you must meet the following criteria:
- Must be a patient of the Oral Surgery Clinic at the University of Michigan School of Dentistry
- Must be scheduled for at least one tooth extraction at Oral Surgery Clinic
- Must be able to understand and willing to cooperate with all study procedures
- Must be able to sign an IRB-approved written consent
- Must have at least two teeth with an intact crown, without any full metallic crown coverage, and/or previous root canal treatments
- 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.
- 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"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry
Ann Arbor, Michigan, 48105
About this study
Official title: Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow
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.
Read the 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.
- Conditions
- Dental Pulp Test
- Being tested
- Pulse Oximetry
- Keywords
- Dental Pulp Test, Vitality Testing, Pulpal Blood Flow Measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximetryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Pulse Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single visit, less than one hour testing
Secondary outcomes (1)
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).
Measured: Single visit, less than one hour testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start12 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Pulp TestStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darya Dabiri, University of Michigan
- Investigators
- Darya Dabiri, DMD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578549
- Sponsor's protocol ID
- HUM00136199
- Status last verified
- Sep 2020
- First submitted
- 22 Jun 2018
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow
- ClinicalTrials.gov ID
- NCT03578549
- Acronym / sponsor ID
- HUM00136199
- Conditions
- Dental Pulp Test
- Keywords
- Dental Pulp Test, Vitality Testing, Pulpal Blood Flow Measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oximetry testing of healthy teeth and those requiring removal | – | Device: Pulse OximetryTo 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, you must meet the following criteria:
- Must be a patient of the Oral Surgery Clinic at the University of Michigan School of Dentistry
- Must be scheduled for at least one tooth extraction at Oral Surgery Clinic
- Must be able to understand and willing to cooperate with all study procedures
- Must be able to sign an IRB-approved written consent
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse OximetryPulse 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. | Device | Oximetry testing of healthy teeth and those requiring removal |
Primary outcome
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp
Time frame: 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.
1 secondary outcome
Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth
Time frame: Single visit, less than one hour testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dental Pulp Test
Not yet recruitingObservational study
PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY
Diabetic Polyneuropathy, Healthy Individuals (Controls)
Not yet recruitingObservational study
Evaluation of Three Pulp Vitality Tests
Dental Pulp Diseases, Dental Pulp Vitality Testing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darya Dabiri, DMD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Test, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp (time frame: Single visit, less than one hour testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.