Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

NCT ID: NCT01660893

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-09-30

Brief Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed Description

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Kovacaine Mist, 3 sprays unilateral

Tetracaine HCl 3% and oxymetazoline HCl 0.05%

Group Type: EXPERIMENTAL

Tetracaine HCl 3% and oxymetazoline HCl 0.05%

Intervention Type: DRUG

3 unilateral intranasal sprays per dose

Tetracaine Only, 3 sprays unilateral

Tetracaine HCl 3%

Group Type: EXPERIMENTAL

Tetracaine HCl 3%

Intervention Type: DRUG

3 unilateral intranasal sprays per dose

Placebo, 3 sprays unilateral

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 unilateral intranasal sprays per dose

Interventions

Tetracaine HCl 3% and oxymetazoline HCl 0.05%

3 unilateral intranasal sprays per dose

Intervention Type: DRUG

Tetracaine HCl 3%

3 unilateral intranasal sprays per dose

Intervention Type: DRUG

Placebo

3 unilateral intranasal sprays per dose

Intervention Type: DRUG

Other Intervention Names

Kovacaine Mist

Eligibility Criteria

Inclusion Criteria

• Male or female 18 years of age or older.
• Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
• Normal lip, nose, eyelid, and cheek sensation.
• Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
• Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
• Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
• Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria

• Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
• Inadequately controlled active thyroid disease of any type.
• Frequent nose bleeds (≥ 5 per month).
• Having received dental care requiring a local anesthetic within the last 24 hours.
• History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
• History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
• Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
• Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
• Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
• Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
• History of congenital or idiopathic methemoglobinemia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triligent International

INDUSTRY

Sponsor Role: collaborator

Rho, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Renatus, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A. Moore, DMD/PhD/MPH

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

University of Maryland, Baltimore

Baltimore, Maryland, United States

Family and Cosmetic Dentistry

Salt Lake City, Utah, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

SR 3-01

Identifier Type: -

Identifier Source: org_study_id