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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- St. Renatus, LLC
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Pulpal Anesthesia
Study Overview
Brief Summary
The 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Kovacaine Nasal Spray
3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
Intervention: 3% tetracaine HCL with 0.05% oxymetazoline HCL (Drug)
Lidocaine Injection
.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
Intervention: Lidocaine Injection (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Soft Tissue Anesthesia Duration(Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes)
- Maximum Change in Pulse From Baseline(Baseline, 15, 20, 30, 40, 50, 60, 120 minutes)
- Maximum Change in Blood Pressure From Baseline(Baseline, 15, 20, 30, 40 50, 60, 120 minutes)
- Maximum Change in Pulse Oximetry From Baseline(Baseline, 15, 20, 30, 40, 50, 60, 120 minutes)