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Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth

NCT01479517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-12-29

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.

Conditions

  • Anesthesia

Interventions

DRUG

Kovacaine Mist 0.1 mL x 4 sprays

Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.

DRUG

Kovacaine Mist 0.2 mL x 2 sprays

Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.

DRUG

Kovacaine Mist 0.2 mL x 1 spray

Dose = 1 intranasal spray of study drug

Sponsors & Collaborators

  • Rho, Inc.

    collaborator INDUSTRY

  • Triligent International

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Principal Investigators

  • Christina Sletten, DDS · Rock Dental Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

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 NCT01479517 on ClinicalTrials.gov