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NCT03578549

Diagnostic Device for the Assessment of Pulpal Blood Flow

Completed Results posted Last updated 19 October 2020
What this trial tests

trial testing Pulse Oximetry in Dental Pulp Test in 30 participants. Completed in 30 June 2019.

Timeline
12 July 2018
Primary endpoint
30 June 2019
30 June 2019

Quick facts

Lead sponsorUniversity of Michigan
StatusCompleted
Study typeOBSERVATIONAL
Enrollment30
Start date12 July 2018
Primary completion30 June 2019
Estimated completion30 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Michigan

Who can join

Adults 18 to 65, any sex, with Dental Pulp Test. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp Primary · 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.

Normal Pulp
GroupValue95% CI
Oximetry Testing of Healthy Teeth and Those Requiring Removal111
Abnormal Pulp
GroupValue95% CI
Oximetry Testing of Healthy Teeth and Those Requiring Removal32
Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth Secondary · Single visit, less than one hour testing

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).

GroupValue95% CI
Oximetry Testing of Healthy Teeth and Those Requiring Removal87.9± 11.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pulse Oximetry

Trials testing the same drug.

Other University of Michigan trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03578549.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing