Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

NCT01302483 | Completed Phase 2 Results

• 1 other identifier: SR 2-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anesthesia Efficacy

Outcome Measures

Primary Outcomes (1)

• Pulpal Anesthesia

  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.

  Continuous throughout dental treatment period (up to 60 minutes)

Secondary Outcomes (4)

• 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

Study Arms (2)

Kovacaine Nasal Spray

EXPERIMENTAL

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

Lidocaine Injection

ACTIVE COMPARATOR

.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine

Drug: Lidocaine Injection

Interventions

3% tetracaine HCL with 0.05% oxymetazoline HCL DRUG

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.

Kovacaine Nasal Spray

Lidocaine Injection DRUG

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.

Lidocaine Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Renatus, LLC: lead
• Ground Zero Pharmaceuticals: collaborator
• Rho, Inc.: collaborator

Study Sites (1)

University of Buffalo

Buffalo, New York, United States

Location

Related Publications (1)

• 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.

  PMID: 23690356 DERIVED

MeSH Terms

Interventions

Tetracaine; Oxymetazoline; Lidocaine

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

The VAS was misadministered such that even subjects with enough pain to require rescue reported essentially no pain on the global VAS. As this would exaggerate the efficacy of the study drug, these measures were not used to calculate its efficacy.

Results Point of Contact

• Title: Dr. Sebastian Ciancio
• Organization: Department of Periodontics & Endodontics, School of Dental Medicine, University of Buffalo, SUNY

ciancio@buffalo.edu

(716) 829-3848

Study Officials

• Sebastian G Ciancio, DDS

  Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: December 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 17, 2015
• Results First Posted: June 17, 2015

Record last verified: 2015-06

Locations

US (1)