N/A
N=30
Diagnostic Device for the Assessment of Pulpal Blood Flow
Dental Pulp Test
Bottom Line
View on ClinicalTrials.gov: NCT03578549 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp — 111; 32 Teeth
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pulse Oximetry (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp |
111; 32 | — |
| SECONDARY Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth |
87.9 | 0.92 |
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.
Eligibility Criteria
Inclusion Criteria
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"
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
Data sourced from ClinicalTrials.gov (NCT03578549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.