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Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

NCT01302483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-06-17

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Ground Zero Pharmaceuticals

    collaborator INDUSTRY

  • Rho, Inc.

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Principal Investigators

  • Sebastian G Ciancio, DDS · Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302483 on ClinicalTrials.gov