Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
|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
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|