Pulp Disease, Dental Clinical Trial
Official title:
Pulpal Blood Flow With the Use of Intra-nasal Anesthetic: a Randomized Double-blind Crossover Study
Anesthetics with vasoconstrictors decrease pulpal blood flow but the impact of intranasal local anesthetics on blood flow is unknown. This blinded, randomized crossover clinical trial will compare the effects of different local anesthetics on anterior teeth in healthy volunteers. On separate study visits patients will receive either traditional injections or intranasal administration of the following solutions: 2% lidocaine with 1:100,000 epi, 3% mepivacaine, tetracaine HCl and oxymetazoline HCl, or saline. The following variables will be assessed: pulpal blood flow, pulpal sensibility, pain on administration, and adverse outcomes.
Informed Consent Prior to screening, informed consent will be obtained from subjects by study
personnel. All questions pertaining to the study will be addressed and answered prior to the
participants' agreement to voluntarily partake. The informed consent explicitly states that
participation, failure to participate, or withdrawal from the study will not impact the
employment or educational standing or any student or employee.
Participants who are screened, selected, provided informed consent, and partake in the 6-week
study will be compensated for their time commitment will receive a total of $100.00. They
will receive $25 for the screening/impression visit if accepted and $25 for each of the
additional 3 sessions.
Study Medications
2% Lidocaine with 1:100,000 epinephrine is the most commonly used local anesthetic in
dentistry. It is associated in with a very small increase in blood pressure and heart rate
due to the vasoconstrictor which is clinically insignificant in healthy adults. Reports of
true allergy in the literature are very rare in a drug that has been administered millions a
times a year for decades. This drug is associated with transient blood flow reduction to the
pulp which is inconsequential to a healthy dental pulp but may have an impact on a tooth that
has sustained dental injury.
3% mepivacaine is another commonly used local anesthetic. It has less inherent vasodilating
properties than other local anesthetics and can be used without a vasoconstrictor. This drug
has been shown to have a reduced impact on pulpal blood flow. However, 3% mepivacaine has a
much shorter duration of action due to the lack of vasoconstrictor and may be of inadequate
duration to manage a dental trauma.
Kovanaze is an intranasal local anesthetic that has been FDA approved for use. It is
comprised of the local anesthetic tetracaine HCl and oxymetazoline which is the primary
ingredient in the drug Afrin. It has been approved for children over 40 kg and adults of all
ages. The impact of Kovanaze is unknown but it would be expected to have no impact on blood
flow as it is administered in an area distant from the blood vessels that supply teeth.
Saline will be administered as a placebo at each study visit so participants only receive one
study drug per session. It will be administered either intranasally or as an injection as the
protocol dictates.
Kovanaze® dose syringes will be stored according to manufacturer's label in refrigeration.
Injectable anesthetics, in vials, will be stored according to manufacturer's labels. All
disposals will comply with manufacturer's labels and meet requirements of those laid out by
federal and state regulations. All three drugs are FDA approved for anesthesia of anterior
teeth. No drug is contraindicated under any procedural circumstance including trauma at this
time and can each be interpreted as fulfilling the standard of care for local anesthesia to
manage a traumatic injury.
Group Assignment
Subjects accepted into the study will be randomized into three different groups that will
determine the order medications are administered using a random number generator. All groups
will be exposed to all three study medications distributed over 3 sessions. Each subject will
serve as their own control. There will be a minimum of a one week washout period between
study visits.
Clinical Visits
At each clinical visit, participants will receive a 3.0ml buccal infiltration of anesthetic
(lidocaine or mepivicaine) or placebo, 0.5ml palatal infiltration of anesthetic (lidocaine or
mepivicaine) or placebo, and 0.4ml (2 sprays, 0.4ml of Kovanaze) or saline placebo in right
nostril. Buccal and palatal infiltrations will be administered by same operator over a one
minute time period. Buccal infiltrations will be administered in labial vestibule above
apices of teeth #7 and #8. Palatal infiltration will be administered in attached keratinized
gingiva near apices of teeth #7 and #8. Each anesthetic syringe will be labeled accordingly
to correspond to material used. The dentist that gives the medicine will know which medicine
is being given but the dentist that later tests the teeth will not know so that bias is
avoided.
i. First visit Study Groups Testing dosage Placebo Group 1 Kovanaze® (2 sprays in right
nostril per manufacture instructions, 0.4ml) Saline buccal infiltrations and palatal
infiltration (3.5ml) Group 2 2% lidocaine with 1: 100, 000 epinephrine buccal infiltration
and palatal infiltration (3.5ml) Saline nasal dosage in right nostril (0.4ml) Group 3 3%
mepivicaine buccal infiltrations and palatal infiltration (3.5ml) Saline nasal dosage in
right nostril (0.4ml)
ii. Second visit Study Groups Testing dosage Placebo Group 1 3% mepivicaine buccal
infiltrations and palatal infiltration (3.5ml) Saline nasal dosage in right nostril (0.4ml)
Group 2 Kovanaze® (2 sprays in right nostril per manufacture instructions, 0.4ml) Saline
buccal infiltrations and palatal infiltration (3.5ml) Group 3 2% lidocaine with 1: 100, 000
epinephrine buccal infiltration and palatal infiltration (3.5ml) Saline nasal dosage in right
nostril (0.4ml)
iii. Third visit Study Groups Testing dosage Placebo Group 1 2% lidocaine with 1: 100, 000
epinephrine buccal infiltration and palatal infiltration (3.5ml) Saline nasal dosage in right
nostril (0.4ml) Group 2 3% mepivicaine buccal infiltrations and palatal infiltration (3.5ml)
Saline nasal dosage in right nostril (0.4ml) Group 3 Kovanaze® (2 sprays in right nostril per
manufacture instructions, 0.4ml) Saline buccal infiltrations and palatal infiltration (3.5ml)
Individual Sensor Holder
The primary determinant of blood flow will be measured by use of noninvasive, objective laser
doppler flowmetry. In order to ensure the laser sensor tip is placed on the same location at
each visit a custom holder from dental putty will be fabricated. This is a standard procedure
in dentistry and involves placing a malleable material on the teeth. This material sets to a
rubbery consistency in a matter of minutes and will allow the study team to adapt the holder
for both the laser doppler tip as well as the pulp tester tip.
The pulp tester is a simple instrument, commonly used in daily practice to measure pulp
sensitivity. See further explanation below. The screening appointment and fabrication of the
sensor holder should not take more than 45 minutes.
Baseline Data Gathering
Prior to any intervention baseline data will be gathered from each patient. An objective
measure of blood flow to the teeth with be gathered by noninvasive laser doppler flowmetry
which requires placement of a probe on the front of the tooth with the assistance of the
custom fabricated holder. Doppler is emerging as the gold standard for assessing pulpal blood
flow in research but its exorbitant expense prohibits its widespread use in clinical
practice.
The efficacy and duration of the local anesthesia will be subjectively tested through
Electric Pulp Testing or EPT. Electric pulp testing tests the sensibility of dental nerves to
an electric current and is one of the most commonly used pulp testing modalities due to its
lack of harm to the dental pulp, reasonable cost, widespread availability, and acceptability
by patients. Every 4 seconds a slight increase in electricity is added until the subject can
feel the electricity. Once any sensation is perceived, testing is discontinued and this value
is recorded. Patients hold the testing probe to provide grounding and they are told to let go
of the probe when they feel sensation precluding any further sensation. This avoids the risk
of injury or pain associated with electric pulp testing.
For both of these procedures a plastic, non-latex rubber dam or barrier is placed to prevent
interference from the gingiva.
Testing visit
Each testing visit is expected to last no more than 1.5 hours. Participants will be asked to
lay in supine position for 10 minutes prior to initiation of testing. To obtund the sensation
associated with an injection, 20% benzocaine topical 3min prior to delivery of anesthesia as
is the standard in clinical dentistry and trauma management. 2.5 mL of 2% Lidocaine with
1:100,000 epi and 3% Mepivacaine by injection. 0.4 mL of Kovanaze will be administered
intranasally.
Laser Doppler Flowmetry readings will be taken at 7, 12, 17, 32, 47, and 62 minutes after
administration of anesthetics. Electronic Pulp Testing will be performed at 5, 10, 15, 30,
45, and 60 minutes.
Subjective data, pertaining to pain and comfort with procedure, will be collected using
questionnaire. Following delivery of anesthetic or placebo a Heft-Parker Visual Analogue
Scale will be utilized to assess pain associated with injection and nasal spray. Patients
will be monitored for adverse reactions during the clinical procedure and although rare, most
adverse reactions related to local anesthesia are acute. The testing visits should last no
more than 90 minutes each.
Upon discharge patients will be reminded to call the emergency contact and seek emergency
medical care for major adverse events. This is unexpected as no major adverse events have
been recorded with Kovanaze and are not encountered in daily use of lidocaine or mepivacaine.
Participants will also be given the take home questionnaire and asked to deliver it to the
student researcher. The following will be addressed in the take home questionnaire:
Heft-Parker Visual Analogue Scale for pain (1 hour after, 4 hours after, 24 hours after),
minor adverse events, and a Likert response scale of patient satisfaction. The questionnaire
takes 5 minutes to take for a total of 15 minutes of questionnaire for each testing visit.
Adverse events will be reported to the IRB, LSUHSC, and the Louisiana State Board of
Dentistry as required by statute. Compensation for injuries will not be provided by study
personnel if an adverse reaction has occurred. Participants will be asked to provide a
contact in case of emergency prior to commencement of testing.
Data collected and interpreted from the research study will be only available to those who
are a part of the research team. Participants information that is collected during the
project will be kept confidential. Participants will be designated a identification number,
rather than name. Only the principal investigator and research member designated to the
current study will be able to obtain the information gathered by participants identification
number. After testing, data collection, documentation of results, and manuscript formulation,
all information, including participant identification number, will be safely locked in filing
cabinet and/or stored on an encrypted password protected computer, in a secure location.
Data Analysis:
The difference between baseline and experimental values for doppler flowmetry and EPT will be
determined and analyzed for each study medication. The means and standard deviations will be
plotted and used in statistical measurements for significance. Data will be analyzed using
ANOVA and Tukey's method for group comparisons.
Outcomes for the Heft Parker Visual Analogue Scale for pain and the Likert Scale for patient
satisfaction will be analyzed using Wilcoxon Rank Sum tests. Reports of adverse events will
be categorized and reported using descriptive statistics.
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