Diagnostic Device for the Assessment of Pulpal Blood Flow

NCT03578549 | Completed Results FDA Device

• 1 other identifier: HUM00136199
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Test

Keywords

Dental Pulp Test; Vitality Testing; Pulpal Blood Flow Measure

Outcome Measures

Primary Outcomes (1)

• 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.

  Single visit, less than one hour testing

Secondary Outcomes (1)

• Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth

  Single visit, less than one hour testing

Study Arms (1)

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

Interventions

Pulse Oximetry DEVICE

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.

Oximetry testing of healthy teeth and those requiring removal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Oral and Maxiofacial Surgery Clinic, U of Michigan School of Dentistry

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Results Point of Contact

• Title: Dr. Darya Dabiri
• Organization: Univeristy of Michigan

daryad@umich.edu

4198821017

Study Officials

• Darya Dabiri, DMD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doc Research Fellow, Faculty of Anesthesiology

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 6, 2018
• Study Start: July 12, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)