Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers
NCT ID: NCT02457806
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Regimen1. Three sprays of Kovacaine Mist in each nostril (bilateral dosing);
* Regimen 2. Three sprays of Kovacaine Mist in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing);
* Regimen 3. Three sprays of Kovacaine Mist in the left nostril and three sprays of placebo in the right nostril (left-sided unilateral dosing);
* Regimen 4. Three sprays of placebo in each nostril (placebo dosing).
During each testing period, eight representative maxillary teeth (#s 3, 4, 6, 8, 9, 11, 13 and 14) will be assessed for anesthesia using standard EPT testing. EPT testing will be conducted on the eight representative teeth at the following time points (minutes relative to the first spray of study drug): T-5, T3, T7, T11, T16, T21, T26T31, T41, T51, T61, T76, T91, T121, T151, and T181. If EPT testing of a target tooth is not possible (e.g., missing or does not meet inclusion criterion #2) tooth substitution is permissible. For molar teeth, #2 may replace #3 and #15 may replace #14. For premolar teeth, #5 may replace #4 and #12 may replace #13. The same replacements will be made for all testing sessions, and the actual teeth tested will be documented in the CRF.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kovacaine Mist
3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Active Spray with deliverable volume of 0.1 mL
Kovacaine Mist and Placebo
3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing) administered 4 minutes apart
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Active Spray with deliverable volume of 0.1 mL
Placebo spray
Aqueous solution to deliver 0.1 mL per unit
Placebo and Kovacaine Mist
3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the left nostril and 3 sprays of placebo in the right nostril (left-sided dosing) administered 4 minutes apart
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Active Spray with deliverable volume of 0.1 mL
Placebo spray
Aqueous solution to deliver 0.1 mL per unit
Placebo spray
3 sprays of placebo in each nostril administered 4 minutes apart
Placebo spray
Aqueous solution to deliver 0.1 mL per unit
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Active Spray with deliverable volume of 0.1 mL
Placebo spray
Aqueous solution to deliver 0.1 mL per unit
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eight representative maxillary teeth \[(3 (or 2), 4 (or 5), 6, 8, 9, 11, 13 (or 12), and 14 (or15)\] free of observable decay (or other pathology), crowns or veneers, all of which have EPT values of 10-50 at screening.
* Normal lip, nose, eyelid, palate, and cheek sensation.
* Patency of both left and right nasal airways.
* Ability to understand and willingness to sign the study informed consent form, communicate with study investigators, and understand and comply with the requirements of the study protocol.
Exclusion Criteria
* Diabetes mellitus.
* Any active thyroid disease other than S/P thyroidectomy on thyroid hormone replacement with TSH values in the normal range.
* History or presence of narrow-angle glaucoma.
* Prostatic enlargement.
* History of sinus/nasal surgery that, in the opinion of the investigator, could confound study results.
* History of frequent nose bleeds.
* Receipt of dental care requiring a local anesthetic within the last 24 hours.
* History of allergy to or intolerance of tetracaine, benzyl alcohol, benzocaine, other ester local anesthetics, succinylcholine, or para-aminobenzoic acid (as found in PABA-containing sunscreens).
* History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite antioxidants.
* History of drug abuse.
* Use of a monoamine oxidase inhibitor within the 3 weeks immediately prior to anticipated study participation.
* Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to undergo pregnancy testing to rule out pregnancy)
* Use of any investigational drug and/or participation in a clinical research trial within 30 days of the first study dosing day.
* Requirement for uninterrupted use of any medication with actions that might, in the opinion of the involved investigator, confound interpretation of study results.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Renatus, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick R Brain, DDS
Role: PRINCIPAL_INVESTIGATOR
Jean Brown Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jean Brown Research
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SR 2-04
Identifier Type: -
Identifier Source: org_study_id