Title
Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
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
Phase
Phase 2Lead Sponsor
St. Renatus, LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dental Anesthesia EfficacyIntervention/Treatment
tetracaine lidocaine oxymetazoline ...Study Participants
45The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.
The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.
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.
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.
3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
Inclusion Criteria: Male or female between 18 and 65 years of age Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes Could breathe through both nostrils Had normal lip, nose, eyelid, and cheek sensations Could understand and sign the informed consent document Could communicate with the investigator Could understand and comply with the requirements of the protocol Exclusion Criteria: Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma Clinically relevant sinus/nasal surgical history Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment site Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis) Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications History of alcoholism and/or drug abuse Had taken a monamine oxidase inhibitor within the past 3 weeks Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy) Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
| Event Type | Organ System | Event Term | Kovacaine Nasal Spray | Lidocaine Injection |
|---|
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.
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 from Baseline at any time point.
Maximum change from Baseline at any time point.
Maximum change from Baseline at any time point
