Clinical trial NCT01710787: Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: operative
dental procedure
Lead sponsor: St. Renatus, LLC
Sponsor class: INDUSTRY
Collaborators: name: Triligent International
name: Rho, Inc.
First posted: 2012-10-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.
timeFrame: at 15 minutes with a 3 minute window
Secondary outcomes:
measure: Intraoral Soft-tissue Anesthesia (Yes/no)
timeFrame: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window
measure: Number of Participants With a Heart Rate Higher Than 125 Bpm
timeFrame: at any time within 120 minutes following drug administration
measure: Number of Participants With a Heart Rate Lower Than 50 Bpm
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Heart Rate
timeFrame: from baseline to 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Systolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Diastolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Heart Rate
timeFrame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Systolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Diastolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: Alcohol Sniff Test
timeFrame: administered at baseline, 120 minutes and approximately 24 hours after drug administration
measure: Intraoral Soft-tissue Anesthesia (Onset and Duration)
timeFrame: up to 120 mins post-dose
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Salt Lake City
country: United States
facility: Family and Cosmetic Dentistry
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: University of Pittsburgh
name: Paul A. Moore, DMD/PhD/MPH
role: STUDY_DIRECTOR
References:
citation: 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.