Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
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|ClinicalTrials.gov Identifier: NCT01302483|
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dental Anesthesia Efficacy||Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL Drug: Lidocaine Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: Kovacaine Nasal Spray
3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL
1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg.
Active Comparator: Lidocaine Injection
.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
Drug: Lidocaine Injection
Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.
- Pulpal Anesthesia [ Time Frame: Continuous throughout dental treatment period (up to 60 minutes) ]Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.
- Soft Tissue Anesthesia Duration [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes ]
Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:
- Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule
- Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule
- Site 3: Incisive papilla
- Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)
- Maximum Change in Pulse From Baseline [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ]Maximum change from Baseline at any time point.
- Maximum Change in Blood Pressure From Baseline [ Time Frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes ]Maximum change from Baseline at any time point.
- Maximum Change in Pulse Oximetry From Baseline [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ]Maximum change from Baseline at any time point
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302483
|United States, New York|
|University of Buffalo|
|Buffalo, New York, United States|
|Principal Investigator:||Sebastian G Ciancio, DDS||Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY|