Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

November 14, 2018 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists class I or II
  • Preoperative heart rate of 55 to 100 beats per minute
  • 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:

  • Inadequately controlled thyroid disease
  • Five or more nosebleeds in the past month
  • Known allergy to any study drug or para-aminobenzoic acid
  • History of methemoglobinemia
  • Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
  • Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intranasal Anesthesia
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.
Drug: Tetracaine HCl and oxymetazoline HCl nasal spray
Two intranasal sprays of anesthetic. Each spray delivers 0.2 mL of solution containing 6 mg tetracaine hydrochloride and 0.1 mg of oxymetazoline hydrochloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients that are successfully anesthetized for endodontic treatment
Time Frame: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Anesthetic success is defined as having sufficiently anesthetize teeth to allow for endodontic treatment.
From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients demonstrating sufficient pulpal anesthesia to commence treatment
Time Frame: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Stage of anesthesia failure
Time Frame: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
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
From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Proportion of premolars vs. anterior teeth successfully anesthetized
Time Frame: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Anesthesia success rate of vital premolars vs. anterior teeth receiving treatment will be compared
From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Time of anesthesia failure after completion of anesthetic administration
Time Frame: From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour)
From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asma Khan, DDS, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-0417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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