Trial Outcomes & Findings for Diagnostic Device for the Assessment of Pulpal Blood Flow (NCT NCT03578549)

Last Updated: 2020-10-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Single visit, less than one hour testing

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	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 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.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diagnostic Device for the Assessment of Pulpal Blood Flow

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oximetry Testing of Healthy Teeth and Those Requiring Removal n=29 Participants 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 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.7 years STANDARD_DEVIATION 13.35 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Single visit, less than one hour testing

Outcome measures

Outcome measures
Measure	Oximetry Testing of Healthy Teeth and Those Requiring Removal n=143 Teeth 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. 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.
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp Normal Pulp	111 Teeth
Subjective Tooth Assessment: Number of Teeth With Normal and Abnormal Pulp Abnormal Pulp	32 Teeth

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Oximetry Testing of Healthy Teeth and Those Requiring Removal n=143 Teeth 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. 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.
Objective Tooth Assessment: Pulse Oximetry Reading for Selected Teeth	87.9 Percentage of saturation Standard Deviation 11.8

Adverse Events

Oximetry Testing of Healthy Teeth and Those Requiring Removal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Darya Dabiri

Univeristy of Michigan

Phone: 4198821017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place