Purpose:

To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze
tetracaine/oxymetazoline nasal spray for root canal treatment of vital premolar and
anterior teeth needing root canal treatment.

Participants:

30 adult patients with a vital upper anterior or premolar tooth (#4-13) with a diagnosis
indicating need root canal treatment and who are seeking treatment in the UNC Chapel Hill
School of Dentistry.

Procedures (methods):

Qualifying patients will be anesthetized with tetracaine/oxymetazoline nasal spray
anesthetic in order to facilitate completion of their clinically required, standard of
care root canal treatment. Research procedures include blood pressure monitoring and pain
assessment using a visual analogue pain scale.

Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

Endodontic Disease

Endodontic Inflammation

Local Anesthesia

Dental Anesthesia

The study will be undertaken in the UNC Chapel Hill School of Dentistry student clinics.
Eligible patients seeking treatment at the School of Dentistry will be recruited to the
study and written informed consent obtained.

Operator Training:

Operators will obtain online and in person training to ensure consistent, accurate use of
the nasal spray. Anesthesia of all study subjects will be performed by UNC Chapel Hill
Graduate Endodontics residents.

Patient Selection:

A total of thirty adult subjects (>18years old) seeking endodontic treatment will be
recruited to the study. Inclusion criteria are: American Society of Anesthesiologists
class I or II; Preoperative heart rate of 55 to 100 beats per minute; a maximum blood
pressure reading of 166/100 mmHg; maxillary anterior tooth or premolar with a diagnosis
or treatment plan which indicates root canal treatment.

Exclusion criteria are based on recommendations made by the FDA label as well the adverse
effects reported in prior clinical trials.

History, examination, and recruitment:

Information including history of present illness, vital signs (heart rate and blood
pressure) and medical history will be obtained. Standardized, calibrated examiners will
perform a standard endodontic clinical exam including the response to cold ascertained
using a cold stimulus (EndoIce, Coltène/Whaledent, Cuyahoga Falls, OH). Written informed
consent will be obtained from patients who meet the study criteria and agree to
participate.

Participating patients will be asked to rate their current pain on a 100 mm Visual
Analogue Scale. No pain will correspond to 0 mm, mild pain as less than 30 mm, moderate
to severe pain from 30 to 100 mm.

Anesthesia:

Two intranasal sprays of anesthetic (each spray 6mg tetracaine HCl, 0.1mg oxymetazoline)
will be administered 4 minutes apart on the side of the tooth to be treated. After an
interval of 10 minutes, pulpal anesthesia will be ascertained by re-evaluating pain level
with the VAS scale, as well as application of a cold stimulus. If adequate pulpal
anesthesia is noted, the operator will commence with treatment. If the patient has a
positive response to cold stimulus on the tooth or a persisting spontaneous moderate to
severe pain on the VAS, then a third spray of tetracaine/oxymetazoline will be
administered. After a time interval of 4 minutes the operator will again test for pulpal
anesthesia. If at this point pulpal anesthesia is not noted then the failure to obtain
adequate anesthesia will be recorded and rescue anesthesia will be provided. Root canal
treatment will be initiated immediately once pulpal anesthesia has been ascertained. A
timer will be started at this point in order to record any subsequent time of failure.

Treatment:

The tooth will be isolated with a rubber dam and the pulp chamber will be accessed with a
high-speed dental handpiece. Standard root canal treatment will subsequently be initiated
and performed. If at any point during treatment the patient feels pain, the procedure
will be stopped and pain intensity will be assessed via the aforementioned VAS pain
scale. A reported moderate to severe pain score will necessitate additional anesthetic.
The stage and time after initiation of treatment that pain occurred (access,
instrumentation, or obturation) will be recorded. After three tetracaine/oxymetazoline
sprays, rescue anesthesia will be administered if a moderate to severe pain score
persists.

Success will be defined as ability to perform complete cleaning and shaping of the
tooth's root(s). If additional rescue anesthesia is required at any point in during
treatment, the nasal spray anesthesia will be considered a failure. If rescue anesthesia
is required during subsequent stages of treatment, the stage will be recorded for
subjective documentation.

Data Analysis:

An exact binomial test with a nominal 0.05 two-sided significance level will have 93%
power to detect the difference between the null hypothesis proportion of 0.5 (random
chance) and the alternative proportion of 0.8 when the sample size is 30. Secondary
analysis will evaluate the proportion of patients that demonstrated sufficient pulpal
anesthesia to commence treatment. For patients who required rescue anesthesia, the stage
of treatment and time until rescue was needed will be analyzed. The success rate of
premolars vs. anterior teeth will also be evaluated.

Tetracaine HCl and oxymetazoline HCl nasal spray

Anesthetic success is defined as having sufficiently anesthetize teeth to allow for
endodontic treatment.

Evaluation of treatment stage (if any) at which anesthesia fails. Progressive stages at
which failure may occur include 1. After Anesthesia 2. While cutting into dentin 3. Upon
access of the pulp 4. Upon instrumentation of the canals

Anesthesia success rate of vital premolars vs. anterior teeth receiving treatment will be
compared

Two intranasal sprays of tetracaine HCl and oxymetazoline HCl nasal spray anesthetic
administered 4 minutes apart into the nostril corresponding to the side of the treated
tooth. If inadequate anesthetic response obtained within 10 minutes, a third spray will
be administered and assessed for effective anesthesia after 4 minutes.

Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?