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AnesthesiaPhase 3NCT01710787

Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults

A Phase 3 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% and Tetracaine HCl 3% in people with Anesthesia, run by St. Renatus, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia
What is being tested?
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% and Tetracaine HCl 3%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
3 sitesUnited States
Study dates
Oct 2012to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18 years of age or older.
  • Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
  • Normal lip, nose, eyelid, and cheek sensation.
  • Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
  • Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
  • Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
  • Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Who cannot join

  • Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
  • Inadequately controlled active thyroid disease of any type.
  • Frequent nose bleeds (≥ 5 per month).
  • Having received dental care requiring a local anesthetic within the last 24 hours.
  • History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
  • History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
Show all 11Show fewer
  • Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
  • Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
  • Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
  • Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
  • History of congenital or idiopathic methemoglobinemia

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Buffalo

    Buffalo, New York, 14214-8004

  • Family and Cosmetic Dentistry

    Salt Lake City, Utah, 84124

  • Jean Brown Research

    Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Read the detailed description

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo. Recruitment will be from diverse dental patient populations.

Conditions
Anesthesia
Being tested
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Tetracaine HCl 3%, Placebo
Keywords
operative, dental procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetracaine HCl 3% and Oxymetazoline HCl 0.05%Drug

    Also called Kovacaine Mist

    3 unilateral intranasal sprays per dose

  • Tetracaine HCl 3%Drug

    Also called Active control

    3 unilateral intranasal sprays per dose

  • PlaceboDrug

    Also called Inactive ingredients

    3 unilateral intranasal sprays per dose

Study groups in NCT01710787
Study groupRoleWhat they receive
Kovacaine Mist, 3 sprays unilateralExperimentalTetracaine HCl 3% and Oxymetazoline HCl 0.05%
Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine Only, 3 sprays unilateralExperimentalTetracaine HCl 3%
Receives: Drug: Tetracaine HCl 3%
Placebo, 3 sprays unilateralPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.

    If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

    Measured: at 15 minutes with a 3 minute window

Secondary outcomes (15)

  1. Intraoral Soft-tissue Anesthesia (Yes/no)

    Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints

    Measured: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window

  2. Number of Participants With a Heart Rate Higher Than 125 Bpm

    Measured: at any time within 120 minutes following drug administration

  3. Number of Participants With a Heart Rate Lower Than 50 Bpm

    Measured: at any time within 120 minutes following drug administration

  4. Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg

    Measured: at any time within 120 minutes following drug administration

  5. Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg

    Measured: at any time within 120 minutes following drug administration

  6. Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg

    Measured: at any time within 120 minutes following drug administration

  7. Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg

    Measured: at any time within 120 minutes following drug administration

  8. Absolute Maximum Change From Baseline in Heart Rate

    Measured: from baseline to 120 minutes following drug administration

  9. Absolute Maximum Change From Baseline in Systolic Blood Pressure

    Measured: from baseline to 120 minutes following drug administration

  10. Absolute Maximum Change From Baseline in Diastolic Blood Pressure

    Measured: from baseline to 120 minutes following drug administration

  11. The Profile Over Time of Heart Rate

    Measured: from baseline to 120 minutes following drug administration

  12. The Profile Over Time of Systolic Blood Pressure

    Measured: from baseline to 120 minutes following drug administration

  13. The Profile Over Time of Diastolic Blood Pressure

    Measured: from baseline to 120 minutes following drug administration

  14. Alcohol Sniff Test

    The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.

    Measured: administered at baseline, 120 minutes and approximately 24 hours after drug administration

  15. Intraoral Soft-tissue Anesthesia (Onset and Duration)

    Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints

    Measured: up to 120 mins post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01710787
Sponsor's protocol ID
SR 3-02
Status last verified
Jul 2017
First submitted
17 Oct 2012
Last updated
30 Aug 2017
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ciancio SG, Marberger AD, Ayoub F, Garlapo DA, Pantera EA Jr, Pantera CT, Al-Mubarak S, Sobieraj BD, He DY, Myneni SR. Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial. J Am Dent Assoc. 2016 May;147(5):339-347.e1. doi: 10.1016/j.adaj.2015.11.009. Epub 2016 Feb 15.

    PubMed 26892312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% and Tetracaine HCl 3% in people with Anesthesia, run by St. Renatus, LLC at 3 sites in United States.

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 7 inclusion and 11 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: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic. (time frame: at 15 minutes with a 3 minute window). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710787, which also lists 1 linked publication.

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 30 Aug 2017.

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