Endodontic DiseasePhase 4NCT03502135
Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment
A Phase 4 study testing Tetracaine HCl and oxymetazoline HCl nasal spray in people with Endodontic Disease and Endodontic Inflammation, run by University of North Carolina, Chapel Hill.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Endodontic Inflammation, Local Anesthesia
- What is being tested?
- Tetracaine HCl and oxymetazoline HCl nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Tetracaine HCl and oxymetazoline HCl nasal spray
- Medical subject headings
- Dental Pulp Diseases, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracaine HCl and oxymetazoline HCl nasal sprayDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Anesthesia | Experimental | 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. Receives: Drug: Tetracaine HCl and oxymetazoline HCl nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that are successfully anesthetized for endodontic treatment
Anesthetic success is defined as having sufficiently anesthetize teeth to allow for endodontic treatment.
Measured: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Secondary outcomes (4)
Proportion of patients demonstrating sufficient pulpal anesthesia to commence treatment
Measured: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Stage of anesthesia failure
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
Measured: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Proportion of premolars vs. anterior teeth successfully anesthetized
Anesthesia success rate of vital premolars vs. anterior teeth receiving treatment will be compared
Measured: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Time of anesthesia failure after completion of anesthetic administration
Measured: From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: study drug not available in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Arm, unblinded trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asma Khan, DDS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502135
- Sponsor's protocol ID
- 17-0417
- Status last verified
- Nov 2018
- First submitted
- 22 Mar 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment
- ClinicalTrials.gov ID
- NCT03502135
- Acronym / sponsor ID
- 17-0417
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study drug not available in time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Arm, unblinded trial.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Anesthesia | Experimental | Drug: Tetracaine HCl and oxymetazoline HCl nasal sprayTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetracaine HCl and oxymetazoline HCl nasal sprayTwo intranasal sprays of anesthetic. Each spray delivers 0.2 mL of solution containing 6 mg tetracaine hydrochloride and 0.1 mg of oxymetazoline hydrochloride | Drug | Intranasal Anesthesia |
Primary outcome
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.
4 secondary outcomes
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)
Stage of anesthesia failure
Time frame: 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)
Time of anesthesia failure after completion of anesthetic administration
Time frame: From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Khan, DDS principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetracaine HCl and oxymetazoline HCl nasal spray in people with Endodontic Disease and Endodontic Inflammation, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.