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Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

This study has been completed.
Sponsor:
Collaborator:
University at Buffalo
Information provided by:
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01302483
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 18, 2011
February 18, 2011
December 2008
January 2009   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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 ]
Same as current
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
Primary Purpose: Supportive Care
Dental Anesthesia Efficacy
  • Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
    Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses). The total dose of tetracaine HCl/oxymetazoline HCl was 18 mg/0.3 mg.
    Other Name: Kovacaine Nasal Spray
  • Drug: Lidocaine Injection
    Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses).
  • Experimental: Kovacaine Nasal Spray
    Intervention: Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
  • Active Comparator: Lidocaine Injection
    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 VAX > 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 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
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01302483
SR 2-01
Not Provided
Jim Mulvahill, St. Renatus, LLC
St. Renatus, LLC
University at Buffalo
Principal Investigator: Sebastian G Ciancio, DDS Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
St. Renatus, LLC
February 2011

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