Pulse Oximeter is a Potential Diagnostic Device for the Assessment of Pulpal Blood Flow
Conditions: Dental Pulp Test
Sponsor: University of Michigan

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Assessment of Tooth Vitality Using Pulse Oximeter 
 
NCT03578549 
Principal Investigator:  Clauw, Daniel 
 
 
 
 
Post-Doc Fellow: Dabiri, Darya 
Draft or Version Number:  7.0 
July 3, 2019 
 

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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the Code of Federal Regulations on the Protection 
of Human Subjects (45 CFR Part 46). All personnel involved in the conduct of this study have 
completed human subjects’ protection training.   

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this study will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
 
 
Name: Daniel Clauw 
 
Title: Professor, Department of Anesthesiology, University of Michigan 
 

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TABLE OF CONTENTS 
 
 
PAGE 
STATEMENT OF COMPLIANCE .................................................................................................... 1 
SIGNATURE PAGE ............................................................................................................................ 2 
TABLE OF CONTENTS ..................................................................................................................... 3 
LIST OF ABBREVIATIONS.............................................................................................................. 5 
PROTOCOL SUMMARY ................................................................................................................... 6 
SCHEMATIC OF STUDY DESIGN: ................................................................................................ 7 
KEY ROLES AND CONTACT INFORMATION............................................................................ 9 
1 
INTRODUCTION:  BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
 .................................................................................................................................................... 11 
 
Background Information .............................................................................................. 11 
 
Rationale ....................................................................................................................... 12 
 
Potential Risks and Benefits ........................................................................................ 12 
1.3.1 Potential Risks .................................................................................................. 12 
1.3.2 Potential Benefits ............................................................................................. 15 
2 
OBJECTIVES ........................................................................................................................... 16 
 
Study Objectives ........................................................................................................... 16 
 
Study Outcome Measures ............................................................................................ 16 
3 
STUDY DESIGN ...................................................................................................................... 18 
4 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................ 20 
 
Subject Inclusion Criteria............................................................................................. 20 
 
Subject Exclusion Criteria ........................................................................................... 20 
 
Strategies for Recruitment and Retention ................................................................... 20 
4.3.1 Reasons for Withdrawal .................................................................................. 20 
4.3.2 Handling of Subject Withdrawals ................................................................... 21 
 
Premature Termination or Suspension of Study ......................................................... 21 
5 
STUDY SCHEDULE ............................................................................................................... 22 
 
Screening ....................................................................................................................... 22 
 
Enrollment/Baseline (Day 0, visit 1) ........................................................................... 22 
 
Study Visit (Procedure Appointment) ......................................................................... 22 
 
Withdrawal Visit........................................................................................................... 22 
6 
STUDY PROCEDURES/EVALUATIONS: .......................................................................... 23 
 
Study Procedures/Evaluations ..................................................................................... 23 
 
Laboratory Procedures/Evaluations ............................................................................ 23 
 
Study Specific Biospecimens....................................................................................... 23 
6.3.1 Specimen Collection Procedures .................................................................... 23 
6.3.2 Specimen Preparation, Handling, and Storage ............................................... 23 
6.3.3 Specimen Shipment ......................................................................................... 23 

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Questionnaire Administration ...................................................................................... 23 
7 
ASSESSMENT OF SAFETY .................................................................................................. 24 
 
Specification of Safety Parameters .............................................................................. 24 
7.1.1 Unanticipated Problems ................................................................................... 24 
7.1.2 Serious Adverse Events ................................................................................... 24 
 
Reporting Procedures ................................................................................................... 25 
8 
STUDY OVERSIGHT ............................................................................................................. 26 
9 
CLINICAL SITE MONITORING ........................................................................................... 27 
10 
STATISTICAL CONSIDERATIONS .................................................................................... 28 
 
Study Hypotheses ......................................................................................................... 28 
 
Sample Size Considerations ......................................................................................... 28 
 
Final Analysis Plan ....................................................................................................... 28 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .............. 29 
12 
QUALITY CONTROL AND QUALITY ASSURANCE ..................................................... 30 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS: ............................................................. 31 
 
Ethical Standard ............................................................................................................ 31 
 
Institutional Review Board .......................................................................................... 31 
 
Informed Consent Process ........................................................................................... 31 
 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 31 
 
Participant Confidentiality ........................................................................................... 31 
 
Future Use of Stored Specimens and Other Identifiable Data ................................... 32 
14 
DATA HANDLING AND RECORD KEEPING .................................................................. 33 
 
Data Management Responsibilities ............................................................................. 33 
 
Data Capture Methods .................................................................................................. 33 
 
Types of Data ................................................................................................................ 33 
 
Schedule and Content of Reports ................................................................................ 34 
 
Study Records Retention .............................................................................................. 34 
 
Protocol Deviations ...................................................................................................... 34 
15 
PUBLICATION/DATA SHARING POLICY ........................................................................ 35 
16 
LITERATURE REFERENCES ............................................................................................... 36 
17 
QUESTIONNAIRES ................................................................................................................ 37 
18 
FORMS ...................................................................................................................................... 41 
 

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LIST OF ABBREVIATIONS 
 
EPT 
 
 
 
Electrical Pulp Test 
PBF 
 
 
 
Pulpal Blood Flow 
LDF 
 
 
 
Laser Doppler Flowmeter 

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PROTOCOL SUMMARY 
Title: 
Assessment of Tooth Vitality Using Pulse Oximeter 
Précis: 
The vitality of the pulp is determined according to the health of the 
vascular supply not the sensory fibers. Objective diagnostic devices 
that examine pulpal blood flow, such as pulse oximeter have shown 
promising results for the assessment of pulp vitality. This could be 
valuable not only in pulp necrosis but also in diagnosis of 
inflammatory status of the pulp. If blood flow in teeth is related to 
symptoms and/or pathology, this would likely have much broader 
applicability in dentistry, as dentists frequently struggle to answer 
questions such as “is the pain coming from the tooth or another 
structure?”, and “is the tooth alive or dead”.  These are very important 
questions in a wide variety of individuals presenting with acute and 
chronic orofacial pain.  In the present study we will measure pulpal 
blood flow using pulse oximeter in patients who are already 
undergoing extractions. Conventional tooth assessments (percussion, 
palpation, cold, and electrical pulp testing) and pulpal blood flow 
measurements would be used for teeth that are planned for extraction 
and also up to 2-5 additional teeth in each participant. We will then 
look to see whether these clinically measured physiologic indicators of 
tooth vitality are similar to the histological presentation of the 
extracted teeth 
Objectives: 
The objective of this study is to evaluate if pulse oximeter 
measurements are a reliable marker for patient’s reported symptoms 
and/or histological evaluations.   
Population: 
 35 participants  
Site: 
University of Michigan, Ann Arbor MI  
Study Duration: 
24 months 
Subject Participation 
Duration: 
Visit 1: approximately 45 minutes 
 
Estimated Time to 
Complete 
Enrollment: 
 6 months 
 
 
 

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Schematic of Study Design: 
 
 
 
 
 
 
 
 

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Procedure  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study-Related Procedure 
1) 
The researcher will gather information initially by asking if any of the teeth are hurting or sensitive to hot/cold 
2) 
Participant will complete self-report questionaries’ regarding their history of dental pain 
3) 
Existing panoramic radiograph will be reviewed by a member of research team prior to choosing which teeth (less than 
10) will be to be tested.  
4) 
Blood pressure, and heart rate values recorded at this appointment will be obtained from the medical record by a member 
of research team prior to the extraction. 
5) 
The researcher initially will palpate the gum around selected teeth and record any discomfort 
6) 
 A plastic clip, pulse oximeter will be placed over the teeth, one at a time, to measure blood flow by measuring the 
presence of pulse in these teeth for approximately for 15-30 seconds per tooth. 
7) 
The clip will remain on the tooth for additional 2-3 minutes to continually measuring pulse while the following tests are 
taken place: 
a. 
Cold Testing: This test is used to assess if the tooth is “dead” or “alive” by measuring sensation of cold from 
the tooth. A small cotton ball will be sprayed with cold spray (called Endo-Ice) and then placed on the surface 
of that tooth for approximately 15 seconds or till participant reports any sensation of cold. There would be 30 
seconds wait time prior to the next step. 
b. 
Electrical Pulp Testing: This test is used to assess if the tooth is “dead” or “alive” by measuring sensation of 
electrical pulses from the tooth. A small probe attached to an electrical pulp testing (EPT) device will be 
placed on the surface of that tooth for approximately 15 seconds or till participant reports any tingling 
sensation. There would be 30 seconds wait time prior to the next step. 
c. 
Percussion Testing: This test is used to assess if the tooth is “dead” or “alive”. The end of the mouth mirror 
is used to gently tap on the tooth surface and record any discomfort. There would be 30 seconds wait time 
prior to removal of the clip.  
8) 
Once the tests above are completed, the plastic clip will be removed from your tooth.  The pulse oximeter sensors will 
be removed from the plastic clip and replace with the LDF sensor. The plastic clip will be placed back over the teeth 
previously tested to measure the blood flow with the LDF . Blood flow will be measured by the presence of a pulse in 
each tooth for approximately for 15-30 seconds. Once the measurement is obtained, the plastic clip will be removed from 
the tooth. 
9) 
After obtaining participant’s permission, researchers will obtain a de-identified copy of the participants dental 
radiographs  
10) After planned extraction is completed by the oral surgery provider, the tooth/teeth from the standard of care procedure 
will be provided to the researcher for further analysis to determine of the tooth is “alive or dead”. This process will occur 
at the University of Michigan, School Of Dentistry 
Standard care procedures: 
After completion of the study related procedures, patient’s care is transferred to their treating clinician for dental extraction 
Post-Extraction, Histological Analysis: 
Upon completion of extraction, the teeth will be placed in formalin-containing bottle. After formalin fixation, the teeth will be 
prepared for histological examination using 10% EDTA for demineralization. Following that, the teeth are trimmed, embedded in 
paraplast and cut longitudinally to obtain 6um thick section. The sections will be stained with H&E and examined with a light 
microscope. The histological diagnosis is based on the classification used by Seltzer et al. as follows: 

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KEY ROLES AND CONTACT INFORMATION 
 
Principal 
Investigator:   
Daniel Clauw, Research Investigator,  
Chronic Pain and Fatigue Research Center 
Domino's Farms, Lobby M, PO Box 385 
24 Frank Lloyd Wright Dr.  
Ann Arbor, MI 48106, USA 
(p) 734-998-0176 
(f) 734-998-6900 
dclauw@med.umich.edu 
Institutions: 
University of Michigan 
Ann Arbor, MI 48109 USA 
 
 
Key Personnel: 
 
• Daniel J. Clauw, M.D, is a Professor of Medicine 
(Rheumatology), 
Anesthesiology, 
and 
Psychiatry 
at 
the 
University of Michigan (UM) and Director of the world renowned 
CPFRC.  Dr. Clauw is an acknowledged expert in pain conditions 
and has greatly expanded the understanding of the neurobiological 
mechanisms of pain and fatigue in a number of chronic pain 
conditions.  He has also been a prolific mentor, being the primary 
or co-mentor for 25 NIH K awardees, nearly all of which are now 
successful independent researchers.  To this application he brings 
expertise in orafacial pain and clinical interventions including 
study design and analysis.  He has expertise in the techniques 
described in this application including measurement of clinical 
pain, surrogates of centralized pain, and psychophysical pain 
testing.  He has served as the head of research networks and center 
grants investigating chronic pain, and is uniquely suited to 
facilitate contact with other experts and collaborators throughout 
the training and research portions this study. Dr. Clauw will meet 
regularly with the candidate weekly in person and is available for 
additional informal meetings and ad hoc discussions.  
• Steven E. Harte, Ph.D. is an Assistant Research Scientist in the 
Departments of Anesthesiology and Medicine, and is a core 
faculty member of the pain research at the University of Michigan.  
Dr. Harte’s current research uses psychophysical measures and 

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advanced 
neuroimaging 
techniques 
to 
investigate 
the 
pathophysiology of chronic pain.  He has been integral in 
developing and validating novel pain assessment methods and 
devices for research and clinical applications of psychophysical 
testing, including in large multi-site, longitudinal investigations of 
chronic pain. To this application Dr. Harte will provide the 
candidate mentorship on the use of unconventional sensory 
measurements of pain for both assessment of acute pain and 
chronic dental pain.  He will meet regularly with the candidate 
once per month and on an ad hoc basis. 
• Darya Dabiri, DMD, MS. Dr. Dabiri obtained her dental degree 
from the University of British Columbia in 2008. She then 
pursued dual training in pediatric dentistry and endodontics at the 
University of Toledo Medical Center and University of Michigan 
respectively. She has had numerous publication in both basic 
sciences and epidemiological studies looking at host/immune 
responses in viral myocarditis and early childhood caries in the 
developing countries. She pursued training in Master of Clinical 
Research at the University of Michigan and also a K-12 training 
grant through mentorship of the CPFRC faculty and the support 
of National Institute of Dental Research. Her research is devoted 
to better understand ways to take better care of children with 
endodontic issues in particular to establish a non-subjective tooth 
vitality testing device utilizing a variety of techniques. Dr. Dabiri 
will be involved with the collection, analysis and interpretation of 
the data that is being collected in the present study.  
• Grant Kruger, Ph.D. is an Assistant Research Scientist at the 
Engineering Department at the University of Michigan. He is an 
expert in biomedical device design and manufacturing; control 
systems; mathematic modeling, analysis and prediction; software 
engineering; embedded systems development; metrology; process 
monitoring and fault diagnosis; digital signal processing; 
intelligent maintenance systems. He has a longstanding 
collaborative relationship with Drs. Clauw and Harte and together 
they have developed and patented several medical devices that 
perform quantitative sensory testing, similar to that proposed in 
this study.  He will be integral in developing a pulse oximeter 
holder design.  
 
 

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INTRODUCTION:  BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
Background Information 
 
The ideal test to assess pulp status in diagnosis of odontogenic source of pain should 
provide a simple, objective, standardized, reproducible, non-painful, non-injurious, accurate, and 
inexpensive way of assessing the condition of the pulp tissue. (Gutmann 2011) With our current 
subjective measurements for pain assessments, diagnosis and treatment of dental pain in young 
children and children (any age) with cognitive impairment (CI) is very challenging. Studies have 
shown that children with cognitive impairments appear to be more likely to experience significant 
pain on a regular basis than unimpaired children. (Oberlander, O'Donnell et al. 1999, Massaro, 
Ronfani et al. 2014) In dentistry, self-report of pain is one of the essential tool for pain assessment 
and identification of origin of the pain. However, non-verbal children either due to young age of 
CI are unable to self-report reliably and that by itself challenge the clinician to accurately identify 
the source of pain. 
Previous studies have examined non-subjective diagnostic devices such as the pulse 
oximeter, laser Doppler flowmetry and crown surface temperature change, to assess pulp vitality. 
Despite their promising results, these techniques has not become incorporated into dental diagnosis 
standard of care. (Fanibunda 1986, Fanibunda 1986, Schnettler and Wallace 1991, Fratkin, Kenny 
et al. 1999, Radhakrishnan, Munshi et al. 2002, Gopikrishna, Tinagupta et al. 2007, Jafarzadeh 
2009, Anusha, Madhusudhana et al. 2017)  
Pulse oximeter has been one of the earliest methods and most studied. The principle of pulse 
oximeter design is the fact that the arterial component of blood is pulsatile in nature (time varying). 
The purpose of using pulse oximeter is to measure the percentage of oxygenated hemoglobin 
(HbO2) to the total hemoglobin (Hb)- total oxygenated and deoxygenated hemoglobin. Therefore, 
when light is emitted through LED transmission on the human body (eg finger), the amount of 
light that passes through after attenuation from various tissues, it reaches to veins and arteries and 
can indirectly indicate pulsatile component which overcome the contact component.  
Previous studies have shown the potential application of conventional pulse oximeter for 
assessment of the presence of dental pulp vascularity using a modified probe for teeth. 
(Alghaithy and Qualtrough 2017) It also appears that there is a correlation between oxygen 
saturation of pulpal circulation with systemic blood using pulse oximeter.(Schnettler and 
Wallace 1991)  
Objective diagnostic devices such as pulse oximeter could be valuable not only in pulp 
necrosis but also in diagnosis of inflammatory status of the pulp. If blood flow in teeth is related 
to symptoms and/or pathology, this would likely have much broader applicability in dentistry, as 
dentists frequently struggle to answer questions such as “is the pain coming from the tooth or 
another structure?”, and “is the tooth alive or dead”.  These are very important questions in a wide 
variety of individuals presenting with acute and chronic orofacial pain.  In the present study we 
will measure pulpal blood flow using pulse oximeter in patients who are already undergoing 
extractions. We will then look to see whether these clinically measured physiologic indicators of 
tooth vitality are similar to the histological presentation of the extracted teeth. 

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Rationale 
 
 
 The purpose of this study is to assess tooth health by using a pulse oximeter which 
measures the blood flow within the tooth. 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. 
The objective of the study is to measure sensation as well as blood flow in a tooth, for potential 
use in dentistry.  
Our specific aims are: 
Aim - 1:  To measure pulpal blood flow using pulse oximeter and laser Doppler Flowmeter 
(LDF) 
Aim - 2:  To measure tooth vitality using Cold, Electrical Pulp tester (EPT), percussion and 
palpation testing 
Aim - 3:  To assess histological presentation of the pulp the extracted teeth 
Aim - 4: To evaluate the relationships between the Aims 1-3 to determine if pulpal blood 
flow is a reliable indicator of tooth vitality. 
 
 
Potential Risks and Benefits 
1.3.1 
Potential Risks 
 
Hand-held pulse oximeter:  
The pulse oximeter is a non-invasive diagnostic device intended to measure systematic blood 
oxygenation and pulse rate. In this study, we will use a portable pulse oximeter (CMS60D) to 
measure blood flow in the tooth pulp. Clinical decisions will not be based on the results obtained 
from this test.  The signal emitted from the sensor is light, and there is little to no risk associated 
from the pulse oximeter to human tissue. The pulse oximeter is battery operated and the sensors 
are isolated in plastic sheaths. 
 
Infection control measures will be implemented for all items entering the oral cavity.  The pulse 
oximeter sensors will be cleaned with disinfecting wipes (Colorox Healthcare Hydrogen Peroxide 
Cleaner Disinfectant, Colorox Company, Latham, NY) and then individually wrapped with a latex 
free, translucent, elastic barrier (CurelasticTM, Steri-Shield Products, Las Vegas, NV). The 
insulated wiring harness that connects the sensors to the body of the pulse oximeter will also be 
cleaned with disinfecting wipes and then covered with a barrier film (Universal Cover Barrier, 
Patterson Dental, Saint Paul, MN). A custom made sensor holder will be used to hold the pulse 
oximeter sensors onto the teeth (see below for additional details).  The sensor holder will be 
cleaned with disinfecting wipes prior to use.   
 
A new set of sensor holder will be used for each individual patient.  We will plan to re-use the 
sensors total of 1-2 times. At each time, then sensors and its connecting wires will be wiped using 

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alcohol wipe and then covered using protection barrier, "blue tape". After each use, the blue tape 
would be removed and the sensors and its connectors be wiped again with alcohol 
 
Laser Doppler Flowmeter (LDF):  
 
The laser Doppler Flowmeter is a non-invasive diagnostic device intended to provide measurement 
of perfusion. This device is similar to pulse oximetry it identifies the number and velocity of blood 
cells circulating through vasculature. In this study, we will use a portable Laser Doppler 
Flowmeter, manufactured by Perimed Inc. to measure blood flow in the tooth. Clinical decisions 
will not be based on the results obtained from this test.  According to PeriFlux System 5000 
Manual, The PeriFlux PF 5000 Main Unit contains a diode laser emitting continuous divergent 
radiation. This laser light is transmitted to the PF 5000 LDF Unit(s). The PeriFlux System 5000 is 
classified in USA as a class 1 laser which covers the lowest risk laser. The biomedical engineering 
unit qualified this LDF unit in October of 2013 and tagged it with the hospital tag 464212.  
 
The PeriFlux System 5000 laser Doppler measures micro-circulatory blood flow. Laser light is 
applied to the tissue through fiber optics. The laser light hits moving blood cells in the 
microvasculature, and this scatters the light and causes the laser light to change frequency due to 
Doppler shift. The frequency change will depend on the amount of blood cells in the illuminated 
area and the speed of those blood cells. Part of the laser light is returned to a photo detector in 
the instrument. The value from the photo detector is electronically processed and the signal is 
converted into a perfusion rate. 
 
Infection control measures will be implemented for all items entering the oral cavity.  The LDF 
sensors will be cleaned with disinfecting wipes (Colorox Healthcare Hydrogen Peroxide Cleaner 
Disinfectant, Colorox Company, Latham, NY) and then individually wrapped with a latex free, 
translucent, elastic barrier (CurelasticTM, Steri-Shield Products, Las Vegas, NV). The insulated 
wiring harness that connects the sensors to the body of the LDF will also be cleaned with 
disinfecting wipes and then covered with a barrier film (Universal Cover Barrier, Patterson Dental, 
Saint Paul, MN). A custom made sensor holder will be used to hold the LDF sensors onto the teeth 
and/or supporting gingival. The sensor holder will be cleaned with disinfecting wipes prior to use.   
 
A new set of sensor holder will be used for each individual patient.  We will plan to re-use the 
sensors total of 1-2 times. At each time, then sensors and its connecting wires will be wiped using 
alcohol wipe and then covered using protection barrier, "blue tape". After each use, the blue tape 
would be removed and the sensors and its connectors be wiped again with alcohol 
 
Pulse oximeter sensor holder: 
The sensor holder is designed to hold the sensors securely around the teeth. The sensor holders are 
designed in various sizes to accommodate variation in dental anatomies. The first iteration of the 
sensor holder (i.e., “Design-1”) is 3D printed using the Form2Lab Printer (see photo on page 42). 

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The material used is Dental LT Clear Resin (FormsLab, Somerville, MA) as it can produce 
accurate, biocompatible parts ideal for this application. Dental LT Clear is tested at NAMSA 
(Chasse sur Rhône, France) and is certified biocompatible (EN-ISO 10993-1:2009/AC:2010).  
 
Design-1 includes external wings for placement of cotton rolls to increase comfort for the patient. 
The interface between the sensor and the teeth/gingiva is covered with a thick layer (5-8mm) of 
clear Memosil 2 (Kulzer, Hanau, Germany). We have planned on including this interface for 
comfort and also to increase the surface area since the conventional pulse oximeter is against skin 
and muscle and we plan to place it over the tooth. It has round edges and can be additionally 
supported on the tooth using OpalDam paste (Ultradent Products, South Jordan, UT) to minimize 
any risk of accidental abrasion on the adjacent soft tissue. The sensor holder will be disinfected in 
an ethanol solution between each subject. 
 
There is a small chance that a participant may feel slight pressure on their tooth when the clamp is 
placed or that it might pinch the gingival tissue a little. If this occurs, the clamp will be repositioned 
or removed and another size clamp will be used. Some participants might experience pressure from 
the sensor holder around the tooth following the test. If a subject finds any pressures unbearable 
or intolerable, he or she may ask the operator to stop the test and the pressure will be immediately 
removed from the tooth. 
 
Dental pain questionnaire: 
There is possibility of discomfort associated with being asked personal questions about history of 
dental and your overall wellbeing. You may refuse to answer any questions on the questionnaire 
of survey that may be uncomfortable.  
 
Cold testing: 
One of the potential risk of cold testing is temporary mild pain or discomfort at the site of testing. 
If a subject finds the test unbearable or intolerable, he or she may ask the operator to stop the test 
and the cotton ball will be immediately removed from the tooth. 
 
Electrical Pulp testing (EPT): 
One of the potential risk of EPT testing is temporary mild pain or discomfort at the site of testing. 
If a subject finds the test unbearable or intolerable, he or she may ask the operator to stop the test 
and the probe will be immediately removed from the tooth. 
 
Percussion: 
One of the potential risk of percussion testing is temporary mild pain or discomfort at the site of 
testing. If a subject finds the test unbearable or intolerable, he or she may ask the operator to stop 
the test. 

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1.3.2 
Potential Benefits 
Participants are not expected to receive any personal benefits from being in this study.  
 

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OBJECTIVES 
 
Study Objectives 
The purpose of this study is to assess tooth health by using a pulse oximeter which measures the 
blood flow within the tooth. 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. 
 
Our specific aims are: 
Aim - 1:  To measure pulpal blood flow using pulse oximeter and Laser Doppler Flowmeter 
Aim - 2:  To measure tooth vitality using Cold, Electrical Pulp tester (EPT) , percussion and 
palpation testing 
Aim - 3:  To assess histological presentation of the pulp the extracted teeth 
Aim - 4: To evaluate the relationships between the Aims 1-3 to determine if pulpal blood flow 
is a reliable indicator of tooth vitality. 
 
Study Outcome Measures 
Primary Outcomes Measures: Correlation Between Subjective and Objective Measurements of 
Pulpal Status 
- 
Subjective Measurements Pulpal Status: Conventional pulpal diagnosis using cold test 
[Endo Ice, Coltene/Whaledent, Cuyahoga Falls, OH, USA] and Electrical Pulp Test -EPT 
S[Kerr Vitality Scanner, SybronEndo] testing and recorded, along with vertical and lateral 
percussion and palpation responses. Conventional pulpal diagnosis assessment would be 
used for teeth that are planned for extraction and additional teeth (10 total) in each 
participant  
- 
Objective Measurements Pulpal Status: Measurements obtained from pulse oximeter gives 
a series of reading of oxygen saturation level, and pulse. Pulse oximeter measurements 
would be used for teeth that are planned for extraction and also up to 2-5 additional teeth 
in each participant 
Exploratory Outcomes: 
- 
Systemic Vital Sign Measurements: Blood pressure and pulse recording will be obtained 
from the recorded values from the participant's chart.  
- 
Histological Assessment of the Extracted Teeth: Upon completion of extraction, the teeth 
will be placed in formalin-containing bottle. After formalin fixation, the teeth will be 
prepared for histological examination using 10% EDTA for demineralization. Following 
that, the teeth are trimmed, embedded in paraplast and cut longitudinally to obtain 6um 
thick section. The sections were stained with H&E and examined with a light microscope.  

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Laser Doppler Flowmeter (LDF): Measurements obtained from LDF pulse oximeter gives 
a series of reading of blood velocity. LDF measurements would be used for teeth that are 
planned for extraction and also up to 2-5 additional teeth in each participant 
 

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STUDY DESIGN 
Standard Care Procedures: 
Participants may receive the following treatment procedures whether he/she join this study or not: 
• Review of medical and dental history 
• Oral examinations  
• Dental Procedures (e.g., extractions) planned by his/her oral surgery provider 
 
Study-Related Procedure 
• The researcher will gather information initially by asking if any of the teeth are hurting or 
sensitive to hot/cold 
• Participants will complete self-report questionaries’ regarding their history of dental pain 
• Existing panoramic radiograph will be reviewed by a member of research team prior to 
choosing which teeth (less than 10) will be to be tested.  
•  Blood pressure, and heart rate values would be recorded on this appointment from your 
medical record by a member of research team prior to the extraction. 
• The researcher initially will palpate the gum around selected teeth and record any 
discomfort 
• A plastic clip, pulse oximeter will be placed over the teeth, one at a time, to measure blood 
flow by measuring the presence of pulse in these teeth for approximately for 15-30 seconds. 
• The clip will remain on the tooth for additional 2-3 minutes to continually measuring pulse 
while the following tests are taken place: 
o Cold Testing: This test is used to assess if the tooth is “dead” or “alive” by 
measuring sensation of cold from the tooth. A small cotton ball will be sprayed with 
cold spray (called Endo-Ice) and then placed on the surface of that tooth for 
approximately 15 seconds or till participant reports any sensation of cold. There 
would be 30 seconds wait time prior to the next step. 
o Electrical Pulp Testing: This test is used to assess if the tooth is “dead” or “alive” 
by measuring sensation of electrical pulses from the tooth. A small probe attached 
to an electrical pulp testing (EPT) device will be placed on the surface of that tooth 
for approximately 15 seconds or till participant reports any tingling sensation. 
There would be 30 seconds wait time prior to the next step. 
o Percussion Testing: This test is used to assess if the tooth is “dead” or “alive”. The 
end of the mouth mirror is used to gently tap on the tooth surface and record any 
discomfort. There would be 30 seconds wait time prior to removal of the clip.  
o  
• Once the tests above are completed, the plastic clip will be removed from your tooth.  The 
pulse oximeter sensors will be removed from the plastic clip and replace with the LDF 
sensor. The plastic clip will be placed back over the teeth previously tested to measure the 
blood flow with the LDF . Blood flow will be measured by the presence of a pulse in each 
tooth for approximately for 15-30 seconds. Once the measurement is obtained, the plastic 
clip will be removed from the tooth. 

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• After obtaining participant’s permission, researchers will obtain a de-identified copy of the 
participants dental radiographs  
• After planned extraction is completed by the oral surgery provider, the tooth/teeth from the 
standard of care procedure will be provided to the researcher for further analysis to 
determine of the tooth is “alive or dead”. This process will occur at the University of 
Michigan School of Dentistry Oral Surgery Clinics. 
• Upon completion of extraction, the teeth will be placed in formalin-containing bottle. After 
formalin fixation, the teeth will be prepared for histological examination using 10% EDTA 
for demineralization. Following that, the teeth are trimmed, embedded in paraplast and cut 
longitudinally to obtain 6um thick section. The sections were stained with H&E and 
examined with a light microscope. The histological diagnosis are based on the 
classification used by Seltzer et al. as follow: 
1. 
Normal Pulp: Intact, uninflamed pulp 
2. 
Transitional Stage: Intact pulp with scattered inflammatory cells 
3. 
Pulpitis: inflammatory process affecting the coronal and radicular 
4. 
Pulp Necrosis: All pulp tissue is necrotic 

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STUDY ENROLLMENT AND WITHDRAWAL 
 
Subject Inclusion Criteria 
 
In order to be eligible to participate in this study, you must meet the following criteria:  
1. Must be a patient of the University of Michigan School of Dentistry Oral Surgery Clinics  
2. Must be scheduled for at least one tooth extraction at Oral Surgery Clinic 
3. Must be 18 to 65 years old 
4. Must be able to understand and willing to cooperate with all study procedures 
5. Must be able to sign an IRB-approved written consent 
6. Must have at least two teeth with an intact crown, without any full metallic crown coverage, 
and/or previous root canal treatments 
7. 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. 
8. 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” 
 
 
Subject 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 
 
 
 
Strategies for Recruitment and Retention 
Recruitment Process: 
Subject candidates will be identified by screening clinic schedules for extraction treatments and 
reviewing the subject candidate’s dental records as prescreening activities. Subject Withdrawal 
1.8.1 
Reasons for Withdrawal 
Subject participation is strictly voluntary and there is no treatment associated with the study; 
therefore, a subject may withdraw from further participation in the study without penalty or harm. 
Any reason(s) the subject may give for terminating his or her participation will be kept 

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confidential.  No further information will be required of the subject and the subject will be 
compensated for their participation undergone prior to termination. 
 
Study personnel will be authorized to release a subject from further study participation if: 
 
• The researcher believes that it is not in the subject’s best interest to stay in the study. 
• The subject becomes ineligible to participate. 
• The subject’s condition changes such that he or she needs treatment that is not allowed while 
taking part in the study. 
• The subject does not follow instructions from the researchers. 
• The study is suspended or canceled. 
 
1.8.2 
Handling of Subject Withdrawals 
No further information will be required of the subject. Clinical data collected prior to the point of 
withdrawal will be used in the study. Subjects who do not complete the study will be replaced. 
 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party.  If the study is prematurely terminated or 
suspended, the principal investigator will promptly inform the IRB and will provide the reason(s) 
for suspension or termination. 
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to subjects 
• Insufficient adherence to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination of futility 
 

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STUDY SCHEDULE 
 
Screening 
Subject candidates will be identified by screening clinic schedules for dental extraction treatments 
and reviewing the subject candidate’s dental records. Patients that appear to qualify during the pre-
screening process will be contacted directly in person on the day of their regular extraction consult 
appointment. 
  
 
Enrollment/Baseline (Day 0, visit 1) 
Subject candidates will be approached at the time when they present to the dental clinic for the 
consultation prior to their dental extraction. Consent will be obtained when patient showed interest 
in participation in the study. 
 
 
Study Visit (Procedure Appointment) 
Study visit will take approximately 30-45 minutes. This visit includes completing study related 
procedures including completing the questionnaire by the participant, and performing vitality 
testings’ including cold, EPT, percussion, palpation and pulse oximeter recordings. 
 
Withdrawal Visit 
There are many reasons why the researchers may need to end an individual’s participation in the 
study.  Some examples are: 
ü The researcher believes that it is not in your best interest to stay in the study. 
ü You become ineligible to participate. 
ü You do not follow instructions from the researchers. 
ü The study is suspended or canceled. 

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STUDY PROCEDURES/EVALUATIONS:  
 
Study Procedures/Evaluations 
Study procedures will be evaluated continuously throughout this study to evaluate adherence to 
the protocol.  
 
Laboratory Procedures/Evaluations 
Upon completion of extraction, the teeth will be placed in formalin-containing bottle. After 
formalin fixation, the teeth will be prepared for histological examination using 10% EDTA for 
demineralization. Following that, the teeth are trimmed, embedded in paraplast and cut 
longitudinally to obtain 6um thick section. The sections were stained with H&E and examined 
with a light microscope. The histological diagnosis are based on the classification used by Seltzer 
et al. as follow: 
1. 
Normal Pulp: Intact, uninflamed pulp 
2. 
Transitional Stage: Intact pulp with scattered inflammatory cells 
3. 
Pulpitis: inflammatory process affecting the coronal and radicular 
4. 
Pulp Necrosis: All pulp tissue is necrotic 
 
Study Specific Biospecimens 
1.16.1 
Specimen Collection Procedures 
After the study related procedures are completed, dental care is transferred to the Oral Surgeon 
1.16.2 
Specimen Preparation, Handling, and Storage 
Extracted teeth will be collected in “biohazard specimen transfer bag” and labels with their specific 
ID number. They will then be transferred from oral surgery on the same day to the pathology 
laboratory at the school of dentistry for histology. 
1.16.3 
Specimen Shipment 
There is no shipment required for this study. All the specimen histological evaluation will be 
done at the dental school. 
 
Questionnaire Administration 
History of dental and orofacial pain will be collected in person usingvalidated questionnaires;  
1. DePaQ (Validated Dental Pain Questionnaire) 
2. Fibromyalgia Survey Questionnaire (FSQ)  
 

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ASSESSMENT OF SAFETY 
 
Specification of Safety Parameters 
Safety monitoring for this study will focus on unanticipated problems involving risks to 
participants, including unanticipated problems that meet the definition of an adverse event.   
1.18.1 
Unanticipated Problems  
The Office for Human Research Protections (OHRP) considers unanticipated problems involving 
risks to subjects or others to include, in general, any incident, experience, or outcome that meets 
all of the following criteria: 
7. unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied; 
8. related or possibly related to participation in the research (possibly related means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
9. suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
1.18.2 
Serious Adverse Events  
An adverse event (AE) is defined as: “Any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign, symptom, or disease, temporarily associated with the 
subject’s participation in the research, whether or not considered related to the subject’s 
participation in the research.”  AE reporting is explicit to any AEs with a causal relation to the 
study procedure (pulp testing, use of pulse oximeter). Any complications due to the standard of 
care extraction procedure will not be reported as these AEs are not as a result of a casual relation 
to the study procedure. Only AEs that occur during the investigational device testing would be 
reported. An adverse finding can include a significant change in baseline symptoms, abnormal 
assessments or any combination of these.  
Examples of AEs are as follows: 
• 
Changes in the general condition of the patient 
• 
Subjective symptoms offered by or elicited from the patient 
• 
Objective signs observed by the Investigator or other study personnel 
• 
All concurrent diseases that occur after the start of the study, including any change in 
severity or frequency of preexisting dental pain. 
Any participant that has an adverse event will be followed weekly until either the event has 
resolved or the event is considered stable by the participant and the research team.  Adverse events 
that persist for an extended duration (such as over the duration of the study) will also be followed 
weekly until either the event is resolved or considered stable by the PI and the research participant.   

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Reporting Procedures 
All adverse events, regardless of attribution, will be recorded by the Principal Investigator (PI) 
and/or a study team member in the patient’s research file using the AE CRF. In addition, AEs will 
be tracked in aggregate using the AE tracking log. This log will also document corrective actions 
required and attribute severity, relatedness and expectedness.  
The PI will review and acknowledge (by signing the CRF) all recorded adverse events. The U-M 
IRB will receive at least an annual summary of all AEs in aggregate. AEs will be reported within 
7-days of the occurrence notification. Unanticipated problems or privacy violations/breach of 
confidentiality will be treated as serious and also reported within 7-days of occurrence to the 
appropriate oversight body. 

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STUDY OVERSIGHT 
The PI retains primary responsibility for oversight. In addition, the Institutional Review Board of 
the University of Michigan will review and approve the protocol, study procedures and continuing 
reviews.  
Study staff will permit authorized representatives and regulatory agencies to examine (and when 
required by applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity.   
   
 

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CLINICAL SITE MONITORING 
Because the study meets IRB approval, it is continually reviewed by IRB. This study is cross 
sectional and does not involve administration of any clinical treatments. The study involves no 
more than minimal risk to participants. For these reasons, it is our belief that additional monitoring 
of the site is not necessary.  

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STATISTICAL CONSIDERATIONS 
 
Study Hypotheses 
The calculations are based on a comparison of the test results and “true” disease status. The 
sensitivity, specificity, and positive and negative predictive values of heat and cold application and 
electrical pulp tests will be calculated. Teeth are grouped into two categories, healthy, true disease 
(irreversible pulpitis and necrosis). A perfect diagnostic test would always be positive in the 
presence of disease and negative in the absence of disease. Therefore, sensitivity, specificity, and 
positive and negative predictive value have been developed to characterize test accuracy and to 
compute the benefits of test usage. In addition to that, clinical measurements of the extracted teeth 
will be compared with identification of the true disease by histological evaluation for the pulp 
status. 
 
Sample Size Considerations 
35 completer in total  
 
Final Analysis Plan 
To compare accuracy of pulp vitality between traditional tooth vitality testing (Cold and EPT) to 
pulse oximeter reading to determine if the pulse oximeter is a reliable indicator of tooth vitality. 
We will analyze the relationships between these clinical readings using Pearson correlations and/or 
Chi Square tests. We will evaluate repeatability of the measurements within a tooth for the pulse 
oximeter using Bland-Altman plots, intraclass correlation coefficients (ICCs), and the percentage 
of repeat measurements within +/- 0.5 mm along with a 95% confidence interval for the 
percentage. Pulse oximeter reading will be compared against the gold standard (Cold and EPT) 
assessment using paired t-tests, 95% confidence intervals for the difference from the gold standard 
with a 95% confidence interval. The clinical pulpal status will be compared to the histological 
status for the difference using ANOVA and compared for the percentage of measurements with 
+/- gold standard visual assessment of the pulp status using McNemar’s tests. 
 

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SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate dental and research records for this study. Study staff will 
permit authorized representative and regulatory agencies to examine (and when required by 
applicable law, to copy) research records for the purposes of quality assurance reviews, audits 
and evaluation of the study safety, progress and data validity.  

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QUALITY CONTROL AND QUALITY ASSURANCE 
Quality control will be continually monitored by periodic (semi-annual) reviews of the protocol 
and procedures used in the study.  All questionnaire data is reviewed on the day of the participant 
visit for completeness. De-identified data is monitored after collection for various points of quality 
assurance.  

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ETHICS/PROTECTION OF HUMAN SUBJECTS: 
 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 
and by the Institutional Review Board requirements of the University of Michigan.   
 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials and all participant materials have 
been submitted to the IRB for review and approval.  Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented in the study.  Please see 
accompanying IRB application and letters of approval, and Informed Consent document. 
 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation.  Extensive discussion of risks and possible 
benefits of study participation will be provided to participants and their families, if applicable.  A 
consent form describing in detail the study procedures and risks will be given to the participant.  
Consent forms will be IRB-approved, and the participant is required to read and review the 
document or have the document read to him or her.  The principle investigator will explain the 
research study to the participant and answer any questions that may arise.  The participant will 
sign the informed consent document prior to any study-related assessments or procedures.  
Participants will be given the opportunity to discuss the study with their surrogates or think about 
it prior to agreeing to participate.  They may withdraw consent at any time throughout the course 
of the study.  A copy of the signed informed consent document will be given to participants for 
their records.  The rights and welfare of the participants will be protected by emphasizing to them 
that the quality of their clinical care will not be adversely affected if they decline to participate in 
this study.  
The consent process will be documented in the clinical or research record.  
 
Exclusion of Women, Minorities, and Children 
(Special Populations) 
Children below the age of 18 and cognitively impaired adults are excluded from the current study. 
 
Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, and study staff. This 
confidentiality is extended to cover testing of biological samples in addition to any study 
information relating to participants. The study protocol, documentation, data, and all other 
information generated will be held in strict confidence.     

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Future Use of Stored Specimens and Other 
Identifiable Data 
The de-identified extracted teeth will be transferred for histological evaluation on the same day to 
the pathology laboratory at the school of dentistry.  

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DATA HANDLING AND RECORD KEEPING 
Several measures have been taken to reduce the risk of breach of confidentiality. These include 
training of study team members, electronic and physical security measures for data capture and 
storage, and collecting a minimum of identifiable information for each individual. Breach of 
confidentiality will be considered a “definitely related” Serious Adverse Event. As such, it will be 
reported to the University of Michigan IRB within 7 days of occurrence, and a remediation plan 
will be put in place immediately. 
 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the principal investigator and 
study staff under the supervision of the principal investigator.  All source documents and 
laboratory reports must be reviewed by the principal investigator and/or the study team and/or data 
entry staff, who will ensure that they are accurate and complete.  Unanticipated problems must be 
reviewed by the investigator or designee.   
 
Data Capture Methods 
Data will be kept confidential, in part, by assigning each participant an ID number. This number 
will be used to keep track of each individual’s data. Participant names will never be collected or 
stored with research data. Paper copies of the data from questionnaires and radiographic copy of 
each participant will be stored in a locked file cabinet in a locked office. Paper copies of the consent 
document and the payment processing forms (i.e. those containing subject names) will be stored 
in a separate locked filing cabinet away from the data. The PI (or a designee) will retain the keys 
to access these files. 
Participants will complete paper-based questionnaires; no electronic survey completion will occur. 
Data will be verified and checked for completeness and initialed by the principle investigator prior 
to the completion of the visit. All data will be entered into a research database, REDCap and/or 
excel.  
Study data will be collected and may be managed using an electronic data capture tools hosted at 
University of Michigan. REDCap (Research Electronic Data Capture) is a secure, web-based 
application designed to support data capture for research studies, providing: 1) an intuitive 
interface for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources.  
 
Types of Data 
Outcome measure data of cold testing, EPT, percussion, palpation testing and pulse oximeter 
reading will be collected in the study. Extracted teeth that meet the inclusion criteria will be also 
collected for histological evaluation. 

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Schedule and Content of Reports 
De-identification of data occurs with the generation of study documents, including the assignment 
of a unique research ID to each participant’s data. 
 
Study Records Retention 
Study records will be maintained for ten years from the date of the study is completed. 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical Practice, 
or Manual of Procedures requirements.  The noncompliance may be on the part of the subject, the 
investigator, or study staff.  As a result of deviations, corrective actions are to be developed by the 
study staff and implemented promptly. 
These practices are consistent with investigator obligations in:: 
• Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
• Quality Assurance and Quality Control, Section 5.1.1 
• Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents and 
promptly reported the University of Michigan IRB, according to their requirements.    
 

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PUBLICATION 
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LITERATURE REFERENCES 
 
 
Alghaithy, R. A. and A. J. Qualtrough (2017). "Pulp sensibility and vitality tests for diagnosing 
pulpal health in permanent teeth: a critical review." Int Endod J 50(2): 135-142. 
Anusha, B., K. Madhusudhana, S. K. Chinni and Y. Paramesh (2017). "Assessment of Pulp 
Oxygen Saturation Levels by Pulse Oximetry for Pulpal Diseases -A Diagnostic Study." J Clin 
Diagn Res 11(9): Zc36-zc39. 
Fanibunda, K. B. (1986). "Diagnosis of tooth vitality by crown surface temperature 
measurement: a clinical evaluation." J Dent 14(4): 160-164. 
Fanibunda, K. B. (1986). "The feasibility of temperature measurement as a diagnostic procedure 
in human teeth." J Dent 14(3): 126-129. 
Fratkin, R. D., D. J. Kenny and D. H. Johnston (1999). "Evaluation of a laser Doppler flowmeter 
to assess blood flow in human primary incisor teeth." Pediatr Dent 21(1): 53-56. 
Gopikrishna, V., K. Tinagupta and D. Kandaswamy (2007). "Comparison of electrical, thermal, 
and pulse oximetry methods for assessing pulp vitality in recently traumatized teeth." J Endod 
33(5): 531-535. 
Gutmann, J. L. (2011). "Diagnostic pulp testing in dentistry: how far have we come?" J Hist 
Dent 59(3): 126-128. 
Jafarzadeh, H. (2009). "Laser Doppler flowmetry in endodontics: a review." Int Endod J 42(6): 
476-490. 
Massaro, M., L. Ronfani, G. Ferrara, L. Badina, R. Giorgi, F. D'Osualdo, A. Taddio and E. Barbi 
(2014). "A comparison of three scales for measuring pain in children with cognitive 
impairment." Acta Paediatr 103(11): e495-500. 
Oberlander, T. F., M. E. O'Donnell and C. J. Montgomery (1999). "Pain in children with 
significant neurological impairment." J Dev Behav Pediatr 20(4): 235-243. 
Radhakrishnan, S., A. K. Munshi and A. M. Hegde (2002). "Pulse oximetry: a diagnostic 
instrument in pulpal vitality testing." J Clin Pediatr Dent 26(2): 141-145. 
Schnettler, J. M. and J. A. Wallace (1991). "Pulse oximetry as a diagnostic tool of pulpal 
vitality." J Endod 17(10): 488-490. 
 
 
 
 
 
 
 
 
 
 
 
  
 

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QUESTIONNAIRES 

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FORMS 
Assessment of Tooth 
Vitality Using Pulse 
Oximeter 
 
MEASUREMENT 
READING 
ID Number 
FORM  
2 
Date: 
 
Examiner: 
 
 
SPECIMENS 
How many teeth are selected? 
 
How many of them are treatment planned 
for extraction? 
 
 
 
MEASURMENTS 
 
Tooth #: 
LOCATION 
READINGS 
Endo Ice (Cold) 
 
 
EPT 
 
 
Pulse Ox 
 
 
Laser Doppler Flowmeter 
 
 
Percussion  
 
 
Palpation 
 
 
 
 
MEASURMENTS 
 
Tooth # 
LOCATION 
READING 
Endo Ice (Cold) 
 
 
EPT 
 
 
Pulse Ox 
 
 

Tooth Vitality Assessment 
Version 7.0 
Protocol 
2019 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________________________ 
Based on NIDCR Clinical Study (Observational) Protocol Template v3.0 - 20140106 
42 
Laser Doppler Flowmeter 
 
 
Percussion 
 
 
Palpation 
 
 
 
 
MEASURMENTS 
 
Tooth # 
LOCATION 
READING 
Endo Ice (Cold) 
 
 
EPT 
 
 
Pulse Ox 
 
 
Laser Doppler Flowmeter 
 
 
Percussion 
 
 
Palpation 
 
 
 
MEASURMENTS 
 
Tooth # 
LOCATION 
READING 
Endo Ice (Cold) 
 
 
EPT 
 
 
Pulse Ox 
 
 
Laser Doppler Flowmeter 
 
 
Percussion 
 
 
Palpation 
 
 
 
 
 
 

Tooth Vitality Assessment 
Version 7.0 
Protocol 
2019 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________________________ 
Based on NIDCR Clinical Study (Observational) Protocol Template v3.0 - 20140106 
43 
 
 
 
 
 
Assessment of Tooth 
Vitality Using Pulse 
Oximeter 
 
Documentation of 
Specimens Collection 
ID Number 
FORM 
3 
Date: 
 
Name of Person Recording 
the Specimen: 
 
 
SPECIMENS 
Extracted tooth/teeth was/were collected 
YES 
NO 
How many teeth were extracted? 
 
IF NOT collected, why? 
 
Date of tooth collection 
 
Are the extracted tooth/teeth placed in formalin-containing bottle? 
 
YES 
NO 
Are the extracted tooth/teeth transferred to the School of Dentistry 
laboratory for further analysis? 
YES 
NO 
ADVERSE EVENTS 
Have there been any adverse events?  
(if “Yes” complete AE form 2 and provide details in “Comments” 
section) 
YES 
NO 
COMMENTS 
 
 
 

Tooth Vitality Assessment 
Version 7.0 
Protocol 
2019 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________________________ 
Based on NIDCR Clinical Study (Observational) Protocol Template v3.0 - 20140106 
44 
 
           
 
 
 
 
 
 
LDF probe holder