Clinical trial NCT05227300
Conditions: Symptomatic Irreversible Pulpitis
Keywords: lidocaine buffered local anesthetic irreversible pulpitis
Sponsor: Indiana University
Start date: 2022-02-14; Completion date: 2022-06-30
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.

Detailed description:
40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Arms: arm 1: Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) arm 2: Standard local anesthetic
Interventions: intervention 1: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution intervention 2: 2% lidocaine with 1:100,000 epinephrine
Intervention descriptions: intervention 1: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic intervention 2: Septodont's standard formulation of 2% lidocaine with epinephrine

Protocol documents:
Prot_SAP_001.pdf: 
 
 
BUFFERED VS. UNBUFFERED LOCAL ANESTHESIA IN MANDIBULAR MOLARS 
DIAGNOSED WITH SYMPTOMATIC IRREVERSIBLE PULPITIS: A CONTROLLED, 
RANDOMIZED, DOUBLE-BLIND STUDY 
 
NCT05227300 
 
 
06/30/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 


PRIMARY MATERIALS 
 
2% lidocaine with 1:100,000 epinephrine (Septodont Inc, New Castle, DE) was the only 
local anesthetic used in our study. A standard dental cartridge of 2% lidocaine w/ 1:100,000 
epinephrine contains 1.8mL of solution, and the adult maximum recommended dose equates to 
500mg (3.3mg/lb or 13.8 cartridges). For reasons of this study, we used a maximum of 3 total 
cartridges (5.4mL or 108mg) of 2% lidocaine w/ 1:100,000 epinephrine as the standard 
anesthetic dosage. The Onset 8.4% Sodium Bicarbonate buffering system is marketed by FDA-
approved Onpharma (Carson City, NV) that recommends its concurrent use with 2% lidocaine 
w/ 1:100k epi. Aside from the sodium bicarbonate buffer itself, Onpharma offers the Onset 
Mixing Pen along with an Onset Cartridge Connector to properly formulate the buffered local 
anesthetic solution. The Onpharma Onset mixing protocol was incorporated to properly prepare 
the buffered 2% lidocaine w/ 1:100,000 epinephrine cartridges. Vitality Scanner 2006 (Vitality 
Scanner 2006; SybronEndo, Orange, CA) is marketed and sold by Kerr Dental, and was used to 
confirm pulpal anesthesia via Electric Pulp Testing (EPT). Endo-Ice (1,1,1,2 tetrafluoroethane; 
Hygenic Corp, Akron, OH) was used to initially confirm vitality and a diagnosis of symptomatic 
irreversible pulpitis. 
 
 
VERIFICATION OF BUFFERING CAPACITY 
 
To verify the advertised buffering capacity of an Onset Sodium Bicarbonate Cartridge, a 
pilot study using 2% lidocaine w/ 1:100k epi with and without an added buffer was completed. 
Both pH strips (Lab Rat Supplies, https://www.labrat-supplies.com) and a calibrated digital pH 
meter (Dr. meter, https://drmeter.com) were used to measure the pH of 2% lidocaine with 1:100k 


epinephrine initially. Following Onpharma’s Onset directions for use, 0.18mL of sodium 
bicarbonate buffer was added to a 1.8mL cartridge of 2% lidocaine with 1:100k epinephrine. 
This quantity of added buffer is commonly suggested by the manufacturer, and a historically 
recommended 10% ratio of sodium bicarbonate buffer to local anesthetic. The respective pH of 
each anesthetic group was recorded using each company’s directions for use. Using the pH 
strips, we were able to observe that the 8.4% sodium bicarbonate buffer produced a pH between 
8 and 9, while the calibrated digital pH meter indicated a reading of 8.08. Using the pH strips, 
standard 2% lidocaine w/ 1:100k epi had a pH between 4 and 5, and 2% lidocaine w/ 1:100k epi 
plus 0.18mL of added buffer had a pH between 7 and 8. The digital pH meter produced a reading 
of 4.35 for standard 2% lidocaine w/ 1:100k epi [94], and a pH of 7.34 for 2% lidocaine w/ 
1:100k epi plus 0.18mL of added buffer (no precipitate ever formed). Ultimately, we were able 
to independently verify that the buffering capacity of Onpharma’s Onset sodium bicarbonate 
buffer system is as advertised using 2 different method. 
 
INCLUSION CRITERIA 
To participate, subjects must be between the ages of 18 and 80 years old, have the ability 
and willingness to independently consent to treatment and study participation. They must have 
an uncomplicated medical history (ASA I and II), not be pregnant, and have no allergies to local 
anesthetics/sulfites (confirmed or self-reported). Due to concerns about plasma half-life 
concentrations, they must not be taking any medications that may affect the proper assessment of 
the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 
6 hours [96] [97]; no long-acting NSAIDs such as naproxen within the previous 16 hours). They 
must not require nitrous oxide during treatment, and the injection area should appear healthy 


with no other pre-existing conditions or infections that may compromise an accurate collection 
of data. Since a localized periodontal examination is a routine portion of the endodontic 
examination, the potential presence of periodontal disease will not interfere in making a proper 
endodontic diagnosis. Subjects also must be experiencing signs of irreversible pulpitis (an 
exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the 
time of conducting the study. 
 
EXCLUSION CRITERIA 
No subjects will have a negative response to cold in the proposed treatment tooth. Also, 
no subject may have a radiographic periradicular pathosis more advanced than a widened 
periodontal ligament or have an intraoral swelling. 
 
RECRUITMENT AND ENROLLMENT OF EXPERIMENTAL SUBJECTS 
Potential research subjects were pooled from patients scheduled to receive an endodontic 
evaluation and/or a non-surgical root canal therapy (NSRCT) in the Graduate Endodontic clinic 
at Indiana University School of Dentistry. All 7 endodontic residents were eligible to screen, 
diagnose, explain the study goals, and consent patients presenting to the graduate clinic with 
symptomatic irreversible pulpitis of a mandibular molar. It is important to note that a general 
script was provided to each endodontic resident outlining key points to discuss with prospective 
study participants to establish some uniformity in the consenting process and calibration of 
residents. Each prospective study participant was explicitly made aware that using 2% lidocaine 


w/ 1:100k epi is a standard anesthetic option in endodontic treatment regardless of their 
participation in the research study and the addition of a sodium bicarbonate buffer would not 
lead to a decrease in its efficacy. Participants were further informed that the addition of the 
buffer would either have no effect or actually improve the efficacy of a standard, customary local 
anesthetic.  
If an endodontic resident other than the student researcher made a relevant diagnosis, all 
inclusion/exclusion criteria were respected, and the patient consented to both an NSRCT and 
participating in the study, then the student researcher was notified. Once the student researcher 
confirmed all pre-requisites and answered any questions, a trained research assistant prepared a 
maximum of 3 cartridges of the respective local anesthetic formulation as determined by the 
randomization scheme immediately prior to the planned administration. A professional 
statistician helped provide a two-product randomization scheme that randomized each of the 
potential 60 subjects on the order of their entry into the study. Only the blinded student 
researcher was eligible to administer the local anesthetic. However, all endodontic residents were 
calibrated and eligible to acquire and record the data (soft tissue anesthesia as later described, 
EPT readings, and any pertinent patient discomfort experienced upon access/pulpotomy as 
reflected on the Wong-Baker FACES Visual Analog Scale) obtained after the student researcher 
finished giving all 3 cartridges of anesthetic.   
 
DIAGNOSIS 
The patient’s current chief complaint was recorded; “It hurts when I drink cold...”, etc. 
The tooth/teeth that the patient complained about and the control teeth were subject to standard 
pulp sensibility testing to ensure a proper diagnosis of symptomatic irreversible pulpitis. If 


applicable, this diagnosis was specifically confirmed on the same day that the warranted 
endodontic treatment was rendered. Prospective study participants were given brief instructions 
on cold and EPT usage/expectations. Regarding the cold testing, a cotton pellet was held with 
cotton forceps and thoroughly sprayed with Endo-Ice (Coltene) at -26.2 Celsius until the cotton 
pellet was soaked. The cotton pellet was then applied to the mid-buccal, natural surface of the 
tooth, and the patient’s response was monitored. The soaked cotton pellet was removed once the 
patient felt a painful sensation on the tested tooth or if no sensation was felt after 10 seconds of 
an application. If pain was felt, the amount of time until the sensation subsided was measured. A 
continued pain for 10 seconds or longer was considered “lingering” pain. Exaggerated or 
lingering pain, as compared to adjacent or control teeth, was considered acute pain and further 
quantified on the Wong-Baker FACES Visual Analog Scale (VAS), ranging from 0-10. Patients 
were immediately presented with this VAS, and their baseline response was recorded. After any 
previously induced pain had subsided, an electrical pulp testing exam was done using an Electric 
Pulp Tester (EPT) Sybron Analytic to establish a baseline reading. A 2-3 mm dab of toothpaste 
was placed on the dried buccal tooth structure. The tip of the EPT was placed on the toothpaste 
and the EPT was activated once the patient held the end of the wand, thereby completing the 
circuit. The test was stopped when the patient felt pain or a “tingling” sensation after letting go 
of the wand or if the measurements reached a maximum value of 80. The EPT number was 
recorded by the resident on a designated data sheet. Ultimately, a diagnosis of symptomatic 
irreversible pulpitis was made if the patient had acute, lingering pain cold as compared to the 
control tooth. 
 
BUFFERED ANESTHETIC PREPARATION 


Although other local anesthetics may still be employed, Onpharma markets its Onset sodium 
bicarbonate buffer to ideally be used in combination with a standard cartridge of 2% lidocaine w/ 
1:100k epi. Each of the Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive 
Solution cartridges contain 1.7 mL volume and are packaged in a four-cartridge package. A 
single cartridge can buffer 10 injections, 40 injections per 4-pack. Onset Sodium Bicarbonate 
Cartridges have a 3-year shelf life, but once a cartridge is placed in the Mixing Pen, the cartridge 
should ideally be used within 7 days. Before using, the Onset Mixing Pen was disassembled into 
its 2 parts, and a 3mL size cartridge was inserted into the Cartridge Chamber. The Mixing Pen 
should be re-assembled, and a 2nd fluid container (the 1.8mL anesthetic cartridge) was attached 
to the end of the Pen. To assist the attachment of the anesthetic cartridge to the end of the Pen, an 
Onset Cartridge Connector was used. Each number on the Mixing Pen corresponds with 
approximately .01 mL's of fluid, so the Pen's volume dispensing dial was adjusted to setting 
“18.” Ultimately 0.18mL of 8.4% sodium bicarbonate was transferred from the 3mL size 
cartridge into the lidocaine cartridge after the equivalent amount of anesthetic was displaced into 
the holding reservoir, resulting in a 10% buffered local anesthetic. This process was repeated by 
a trained research assistant to produce 3 equivalently buffered cartridges of 2% lidocaine with 
1:100,000 epinephrine immediately before it was given to the blinded student researcher.  
 
QUALITY ASSURANCE 
The same calibrated electronic pH meter (Dr.meter PH838) that was employed to test the 
pH in the pilot study was used to test a Sodium Bicarbonate Cartridge from the experimental 
pack and a cartridge of the standard 2% lidocaine w/ 1:100k epi from an experimental anesthetic 
package prior to the first administration of the study. Using the pH strips, standard 2% lidocaine 


w/ 1:100k epi had a pH between 4 and 5, and 2% lidocaine w/ 1:100k epi plus 0.18mL of added 
buffer had a pH between 7 and 8. The digital pH meter produced a reading of 4.99 for standard 
2% lidocaine w/ 1:100k epi, and a pH of 7.14 for 2% lidocaine w/ 1:100k epi plus 0.18mL of 
added buffer (no precipitate ever formed). These quality assurance measures are reflected in 
Figures 11-14. Ultimately, we were again able to independently verify that the buffering capacity 
of Onpharma’s Onset sodium bicarbonate buffer system is as advertised using 2 different 
methods [94, 95] prior to using those packages of local anesthetic and Onset buffer on our first 
research participant. 
 
ANESTHETIC ADMINISTRATION 
After applying topical benzocaine to the respective administration sites for 1 minute, the 
student researcher administered 2 cartridges (3.6mL) of the previously determined formulation of 
2% lidocaine w/ 1:100,000 epinephrine via IANB at the rate of 1.8mL per minute. Any patients 
who did not have signs of soft tissue anesthesia (successful IANB) within the following 10 
minutes would receive a supplementary 1/2 cartridge (0.9mL) of the same anesthetic formulation 
via buccal infiltration and a 1/2 cartridge (0.9mL) via lingual infiltration at the affected tooth’s 
apex with a rate of 1.8mL per minute. Along with being a commonplace clinical practice, 
previous studies have demonstrated an added effectiveness of supplementary buccal and lingual 
infiltrations in obtaining pulpal anesthesia. 
 
ANESTHETIC TESTING AND DOCUMENTATION 
Using an online stopwatch, the student researcher started the timer after administering 
both IANBs and then continually assessed soft tissue anesthesia of the respective side of the 


mandible. Soft tissue anesthesia was considered profound when the patient subjectively attested 
that their lip, chin, and tongue on the respective treatment side felt “full” or “numb,” and a light 
stimulation with the tip of an explorer did not elicit any sensation other than pressure as 
compared to a “sharp” feeling the contralateral side. In the event that the patient denied any signs 
of soft tissue anesthesia (absolutely no change in feeling) 10 minutes after the 2 cartridges of 
anesthetic were given via inferior alveolar nerve block (IANB), then the blocks were to be 
considered “missed,” and the patient would need to be re-blocked as clinically appropriate. This 
situation would be grounds for withdrawing the patient from the study (with documentation) 
since a lack of anesthesia following the protocol cannot be attributed to the anesthetic 
formulation itself but rather operator technique/variable patient anatomy.  
Once the patient attested to having soft tissue anesthesia, the amount of time surpassed 
since being blocked was documented on the designated datasheet, and the supplemental buccal 
and lingual infiltrations were then administered as previously described. The student researcher 
or other residents waited 2 minutes after all 3 cartridges of local anesthesia had been 
administered and then obtained an updated EPT reading on the tooth being treated. An EPT=80 
(maximum stimulation) indicated profound pulpal anesthesia, and the endodontic access was 
initiated. An EPT¹80 indicated a need to wait an additional time. We retested the tooth being 
treated using EPT at 2-minute intervals until EPT=80 or when a maximum of 20 minutes had 
passed since administering 2 IANBs. According to Whitcomb et al., waiting 10-15 minutes after 
administering the IANB should be adequate time to allow the onset of pulpal anesthesia in 
molars. Once EPT=80, the reading was reconfirmed in order to get a consecutive EPT=80 a 
minute after the initial reading. Participants who did not demonstrate total soft tissue and/or 
pulpal anesthesia within 20 minutes would be categorized as a failure and further managed 


according to the best clinical practice (additional block/supplementary injections) so that the 
endodontic treatment could continue appropriately. After confirming soft tissue anesthesia and 2 
consecutive EPT=80, the endodontic treatment could begin.  
Upon the completion of the pulpotomy, the patient was shown the same Visual Analog 
Scale to re-assess their level of comfort. However, any discomfort recognized during the pulpal 
access or pulpotomy paused the procedure, and the VAS was shown immediately. Patients who 
indicated moderate or severe pain (VAS scores of 4 or higher) elicited from the tooth undergoing 
treatment upon pulpal access or a complete pulpotomy were categorized as an anesthesia failure 
(lack of profoundness) and appropriately managed as previously described. Patients who 
indicated no pain or mild pain (VAS scores of 3 or lower) were categorized as an anesthesia 
success (obtained profoundness), and the endodontic treatment continued. When co-residents 
rendered the clinical endodontic treatment, they recorded and reported these failures to the 
student researcher after appropriately treating their patient. The student researcher charted the 
data for each uniquely identified study participant regarding the initial EPT readings (treated 
tooth and control), the amount of time taken to reach both soft tissue and pulpal anesthesia, VAS 
scores after both cold testing (baseline) and pulpotomy, and any other conditions that may have 
led to a “failed” profoundness of anesthesia.  
 
STUDY PROCEDURES 
1. Reviewed medical history as a standard of care for endodontic treatment (about 3-5 
minutes) 
2. Standard of care dental exam with sensibility testing that established baseline EPT 
reading and VAS score (about 5-10 minutes) 


3. Reviewed inclusion/exclusion criteria using data collected in steps 1 and 2 for a 
standard of care to ensure that the subject qualified to continue with the study (about 
3 minutes) 
4. Performed consenting procedures for both the Non-surgical Root Canal Therapy 
(NSRCT) and the research study (about 5-10 minutes) 
5. A trained research assistant prepared the cartridges of the type of anesthetic 
formulation (buffered vs. unbuffered) determined by the randomization scheme in a 
separate room immediately prior to it being administered. The assistant made a record 
using a unique identifying code for the type given to each patient. The Onpharma 
Onset protocol was used when indicated. The assistant “prepared” the unbuffered 
cartridges in the same amount of time as required for the buffered cartridges, as well 
as “puncturing” the unbuffered cartridges with the Onset pen so that each cartridge 
had a uniform appearance (about 3 minutes) 
6. Applied 20% topical benzocaine jelly (Ultradent Products Inc, South Jordan, UT) 
after thoroughly drying the tissues surrounding the inferior alveolar nerve block 
(IANB) injection site, buccal vestibule, and lingual vestibule of the treatment tooth 
(about 1 minute)   
7. The student researcher administered the 2 IANBs (about 2 minutes) and then started 
the timer immediately 
8. The patient was regularly re-assessed for soft tissue anesthesia (as previously 
described) 
a. If within 10 minutes the patient had confirmed soft tissue anesthesia, then the 
IANBs were considered successful, and 1 cartridge of the respective 


anesthetic formulation was supplementarily administered via apical buccal 
and lingual infiltrations (documented exact time elapsed) 
b. If at 10 minutes the patient did not have any indications of soft tissue 
anesthesia, then IANBs would be considered missed, and the patient would be 
withdrawn from the study. Administer additional local anesthetic as clinically 
appropriate 
9. Tested the treatment tooth using EPT in 2-minute intervals (starting at 2 minutes post-
supplementary infiltrations) 
a. If within 20 minutes post-IANBs pulpal anesthesia was confirmed with 2 
consecutive EPT=80, initiated NSRCT (document exact time elapsed) 
b. If at 20 minutes post-IANBs pulpal anesthesia was not confirmed with 2 
consecutive EPT=80, anesthesia was considered a failure, and additional local 
anesthetic was administered as clinically appropriate 
10. All pertinent data, including the patient’s VAS comfort assessment after pulp 
chamber access/pulpotomy, were recorded and analyzed with the help a professional 
statistician for statistical significance.  
 
STATISTICAL ANALYSIS 
 
The buffered anesthetic and unbuffered anesthetic groups were compared for differences 
in the percentage of subjects who achieved profound pulpal anesthesia using chi-square tests. 
The time needed to achieve profound pulpal anesthesia using buffered anesthetics and 
unbuffered anesthetics was compared using Kaplan-Meier survival curves and log-rank tests. A 
5% significance level was used for all tests. Comparisons of the VAS results were made using a 


Wilcoxon Rank Sum test. Up to 60 subjects were randomized to ensure that 40 evaluable 
subjects could complete the study. With a sample size of 20 subjects per group, the study had an 
80% power to detect a difference between 90% and 50% of subjects who achieved profound 
pulpal anesthesia. Calculations were based on a chi-square test with a two-sided 5% significance 
level. Sample size calculations were performed using PASS 2019 (NCSS, LLC. Kaysville, UT). 
All calculations were derived with professional assistance. 

ICF_000.pdf: 
 
December 14, 2021 
 
 
 
 
 
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INDIANA UNIVERSITY INFORMED CONSENT STATEMENT AND AUTHORIZATION FOR RESEARCH 
Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed with Symptomatic Irreversible 
Pulpitis: A Controlled, Randomized, Double-blind Study        
Protocol # 11447 
 
ABOUT THIS RESEARCH  
You are being asked to participate in a research study.  Scientists do research to answer important 
questions which might help change or improve the way we do things in the future.  
 
This consent and authorization form will give you information about this study to help you decide 
whether you want to participate.  It is your choice whether or not you want to be in this research 
study.  Please read this form, and ask any questions you have, before agreeing to be in this study.  
 
WHY IS THIS STUDY BEING DONE? 
  
The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will 
work better at numbing the nerve in a tooth than using a different type of anesthetic. A second 
purpose is to see if the time needed to numb the nerve in a tooth is different between the two 
anesthetics. 
  
Both anesthetics are currently marketed (meaning your dentist uses them during standard of care 
procedures).  This study is being done because while both are used regularly with root canal 
procedures, there has not been a study looking at whether one helps to better numb the nerve in the 
tooth in a short time period than the other. 
 
We are asking you to be in this study because you are having a root canal procedure that requires 
anesthetic. 
 
The study is being conducted by Dr. Ken Spolnik, and student researcher, Dr. Peter Alena, of the 
Indiana University School of Dentistry. 
 
WHAT WILL HAPPEN DURING THE STUDY? 
You will first be screened at your regularly scheduled appointment to determine if you qualify to be in 
the study (like reviewing your medical history and dental exam).   The study procedures may be 
conducted at that same visit or at a second regularly scheduled dental visit.  Regardless, the following 
steps will be performed as a part of the study procedures. 
 
1) 
 We will ask you some questions, such as your age and any previous reactions to 
anesthetics, to ensure you qualify to be in the study. 


 
December 14, 2021 
 
 
 
 
 
          Page 2 of 5 
2) 
 You will sign a treatment consent to consent to your standard of care root canal 
treatment. You will then sign this consent form to agree to participate in this study.  The 
signing of the consent forms will take about 5-10 minutes each. 
3) 
 A trained research assistant will use a product assignment sheet to prepare the type of 
anesthetic formulation you have been randomly (like pulling from a hat) assigned to.  This 
will take about 5-10 minutes. 
4) 
 The dentist will apply anesthetic directly to your gums to numb your gum tissue prior to 
the anesthetic injection.  This standard of care procedure, which will be completed 
regardless of participation in this study, will take about one minute. 
5) 
 The student researcher will administer the anesthetic you have been assigned following 
manufacturer’s directions (about 3 minutes) and begin timing how long it takes for you to 
get numb. 
6) 
   The student researcher will test the numbness you feel in the area to be treated until the 
test shows the nerve in your tooth is completely numb.  This will be done by checking how 
long it takes for you to self-report that your lip, chin and tongue feel completely numb and 
a light rubbing of the tip of a dental instrument does not produce more feeling in these 
areas than a light pressure on your tissues.  This will take a maximum of 10 minutes. 
7) 
The dentist performing your root canal will perform the treatment procedure which may 
include testing of the tooth numbness and/or additional anesthetic to specific areas 
around the tooth being treated (these are standard of care procedures, performed 
regardless of your participation in the study).   Once you are confirmed numb and the root 
canal treatment begins, your participation in this study will end.  
 
If you participate in this study, we may learn things about you from the study procedures that could 
be important or interesting to you. Depending on the information, you might need to meet with 
professionals with expertise to help you decide what to do with the information. We do not have 
money or funds available to cover the costs of any follow-up consultations or actions.  We will share 
any abnormal blood pressure or pulse oximetry data we may see during the dental procedure. 
  
WHAT ARE THE RISKS OF TAKING PART IN THE STUDY? 
There is one anesthetic medicine and one buffering agent used in the study.   The anesthetic and 
buffering agent added to the anesthetic are marketed (can be bought by dental practices) and their 
use is considered standard of care in dental procedures involving root canals.   Their use in this study 
is not anticipated to cause any increase risk to you beyond what is normal when used in a root canal 
procedure.  Risks associated with anesthesia and the root canal treatment you will receive, will be 
covered in your treatment consent.   
 
As with any dental procedure, there are risks of trauma or cross contamination.  These risks are not 
considered a part of this study and will be covered in your treatment consent.   
 


 
December 14, 2021 
 
 
 
 
 
          Page 3 of 5 
There is a risk of loss of confidentiality of study records as a part of this study.  This risk will be 
reduced with the following procedures/protections: 
1) Your study records will be identified with a study number, not your name.  Documents such as 
this consent form which will contain your name will be stored in a separate, locked location 
that only study personnel can access.   
2) Electronic study records will be stored in encrypted, password protected computer files that 
only study personnel can access. 
 
WHO WILL PAY FOR MY TREATMENT IF I AM INJURED? 
 If you are injured as a result of participating in this study, you will be responsible for seeking medical  
care and for the expenses associated with any care received. Costs not covered by your health care 
insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health 
care coverage. No money or funds are set aside to pay for these types of injuries. However, you are 
not giving up any legal rights or benefits to which you are otherwise entitled by signing this Informed 
Consent. 
 
WHAT ARE THE BENEFITS OF TAKING PART IN THE STUDY? 
We don’t think you will have any personal benefits from taking part in this study, but we hope to learn 
things that will help others in the future. 
 
WILL I BE PAID FOR PARTICIPATION?  
You will not be paid for participating in this study. 
  
WILL IT COST ME ANYTHING TO PARTICIPATE?  
There is no cost to you for taking part in this study.  However, participation in this study does not 
change your treatment costs. 
  
HOW WILL MY INFORMATION BE USED? 
The study team will collect information about you from your medical records. This information, some 
of which may identify you, may be used for research-related purposes. This may include making sure 
you meet the criteria to be in this study, gathering information about your medical history to include 
in the research data, reviewing results of your medical tests for safety purposes, or to inspect and/or 
copy your research records for quality assurance and data analysis.  
 
The information released and used for this research will include your medical records. Those records 
may contain information related to your mental health, alcohol or substance abuse, HIV/AIDS, 
sexually transmitted diseases, and/or results of genetic testing.  
 
If you agree to participate, you authorize the following to disclose your medical record information:  
• Indiana University School of Dentistry 


 
December 14, 2021 
 
 
 
 
 
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The following individuals and organizations may receive or use your identifiable health information: 
• The researchers and research staff conducting the study 
• The Institutional Review Boards (IRB) or its designees that review this study  
• Indiana University 
• US or foreign governments or agencies as required by law 
• State or Federal agencies with research oversight responsibilities, including but not limited to: 
o The United States Food and Drug Administration (FDA)  
 
Information collected for this study may be used for other research studies or shared with other 
researchers for future research.  If this happens, information that could identify you, such as your 
name and other identifiers, will be removed before any information is shared.  Since identifying 
information will be removed, we will not ask for your additional consent.  
 
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. law. This 
website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time. 
 
HOW WILL MY INFORMATION BE PROTECTED? 
Every effort will be made to keep your personal information confidential, but we cannot guarantee 
absolute confidentiality.  No information which could identify you will be shared in publications about 
this study.   Your personal information may be shared outside the research study if required by law 
and/or to individuals or organizations that oversee the conduct of research studies and these 
individuals or organizations may not be held to the same legal privacy standards as are doctors and 
hospitals.   
 
WHO SHOULD I CALL WITH QUESTIONS OR PROBLEMS? 
For questions about the study contact the researcher, Dr. Ken Spolnik, at 317-274-5311     
In the event of an emergency, you may contact the Graduate Endodontic Department at 317-541-
4218. 
  
For questions about your rights as a research participant, to discuss problems, complaints, or concerns 
about a research study, or to obtain information or to offer input, please contact the IU Human 
Research Protection Program office at 800-696-2949 or at irb@iu.edu. 
 
WHAT IF I DO NOT WANT TO PARTICIPATE OR CHANGE MY MIND? 
After reviewing this form and having your questions answered, you may decide to sign this form and 
agree to participate in the study.  Or, you may choose not to participate in the study. This decision is 
up to you. If you choose not to participate in this study or change your mind after signing this 
document, it will not affect your usual care or treatment or relationship with Indiana University. 


 
December 14, 2021 
 
 
 
 
 
          Page 5 of 5 
 
If you choose to withdraw your authorization for use and disclosure of your protected health 
information, you must do so in writing by notifying Dr. Ken Spolnik at the Indiana University School of 
Dentistry, 1121 W. Michigan Street, Indianapolis, IN. If you withdraw your authorization, you will not 
be able to continue in this study. However, even if you cancel this authorization, the research team, 
research sponsor(s), and/or the research organizations may still use information about you that was 
collected as part of the research project between the date you signed this document and the date you 
cancelled this authorization. This is to protect the quality of the research results. Otherwise, this 
authorization remains valid until the research ends and required monitoring of the study has been 
completed.  
 
The researchers may stop your participation in the study even if you do not want to stop if you are not 
cooperating or it is determined it is not safe for you to continue.  Also, the researcher may withdraw 
your participation if you indicate you have no signs of any kind of numbness 10 minutes after the 
anesthetic was given.  If this happens, you will receive additional anesthetic (as would be standard of 
care for a root canal procedure when the first anesthetic procedure did not take) but data for study 
purposes would no longer be recorded. 
 
 PARTICIPANT’S CONSENT AND AUTHORIZATION 
In consideration of all of the above, I agree to participate in this research study.  I will be given a copy 
of this document to keep for my records.    
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
 
___________________                              ______                    Printed Name of Subject                 
                          
 
____________________                              ________  
 Signature of Subject     
____________ Date      
                                                         
 
______________________                              ___                     Subject’s Address (street, city, state, zip 
code)