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

February 18, 2011
June 16, 2015
December 2008
January 2009   (final data collection date for primary outcome measure)
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.
Pain assessment (pulpal anesthesia) [ Time Frame: Continuous throughout dental treatment period (up to 60 minutes) ] [ Designated as safety issue: No ]
Assessment of need for rescue anesthesia during a dental procedure. In addition, at Baseline, 15, 20, 60 minutes, the efficacy of anesthesia was assessed using the Heft-Parker visual analog scale
Complete list of historical versions of study NCT01302483 on ClinicalTrials.gov Archive Site
  • 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
  • Soft Tissue anesthesia [ 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/cm2 at the tissue site.
  • Pulse and Pulse oximetry [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Dental Anesthesia Efficacy
  • 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.
  • 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.
  • Experimental: Kovacaine Nasal Spray
    3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
    Intervention: Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL
  • Active Comparator: Lidocaine Injection
    .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
    Intervention: Drug: Lidocaine Injection
Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01302483
SR 2-01
Not Provided
Not Provided
Not Provided
St. Renatus, LLC
St. Renatus, LLC
  • Ground Zero Pharmaceuticals
  • Rho, Inc.
Principal Investigator: Sebastian G Ciancio, DDS Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
St. Renatus, LLC
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP