Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

This study has been completed.
Sponsor:
Collaborators:
Ground Zero Pharmaceuticals
Rho, Inc.
Information provided by (Responsible Party):
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01302483
First received: February 18, 2011
Last updated: June 16, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Dental Anesthesia Efficacy
Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL
Drug: Lidocaine Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by St. Renatus, LLC:

Primary Outcome Measures:
  • Pulpal Anesthesia [ Time Frame: Continuous throughout dental treatment period (up to 60 minutes) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Soft Tissue Anesthesia Duration [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Maximum change from Baseline at any time point


Enrollment: 45
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302483

Locations
United States, New York
University of Buffalo
Buffalo, New York, United States
Sponsors and Collaborators
St. Renatus, LLC
Ground Zero Pharmaceuticals
Rho, Inc.
Investigators
Principal Investigator: Sebastian G Ciancio, DDS Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
  More Information

No publications provided by St. Renatus, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01302483     History of Changes
Other Study ID Numbers: SR 2-01
Study First Received: February 18, 2011
Results First Received: March 2, 2011
Last Updated: June 16, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lidocaine
Oxymetazoline
Phenylephrine
Tetracaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015