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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
3 unilateral intranasal sprays per dose
3 unilateral intranasal sprays per dose
3 unilateral intranasal sprays per dose
University of Buffalo
Buffalo, New York, United States
Family and Cosmetic Dentistry
Salt Lake City, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
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.
Time frame: at 15 minutes with a 3 minute window
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
Time frame: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window
Number of Participants With a Heart Rate Higher Than 125 Bpm
Time frame: at any time within 120 minutes following drug administration
Number of Participants With a Heart Rate Lower Than 50 Bpm
Time frame: at any time within 120 minutes following drug administration
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
Time frame: at any time within 120 minutes following drug administration
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
Time frame: at any time within 120 minutes following drug administration
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
Time frame: at any time within 120 minutes following drug administration
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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
Time frame: at any time within 120 minutes following drug administration
Absolute Maximum Change From Baseline in Heart Rate
Time frame: from baseline to 120 minutes following drug administration
Absolute Maximum Change From Baseline in Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
Absolute Maximum Change From Baseline in Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
The Profile Over Time of Heart Rate
Time frame: from baseline to 120 minutes following drug administration
The Profile Over Time of Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
The Profile Over Time of Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
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.
Time frame: administered at baseline, 120 minutes and approximately 24 hours after drug administration
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
Time frame: up to 120 mins post-dose