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

• ClinicalTrials.gov Identifier: NCT01710787
• Recruitment Status: Completed
• First Posted: October 19, 2012
• Results First Posted: August 30, 2017
• Last Update Posted: August 30, 2017
• Sponsor: St. Renatus, LLC
• Collaborators: Triligent International; Rho, Inc.
• Information provided by (Responsible Party): St. Renatus, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Drug: Tetracaine HCl 3%; Drug: Placebo	Phase 3

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.

The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo. Recruitment will be from diverse dental patient populations.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
• Study Start Date: October 2012
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kovacaine Mist, 3 sprays unilateral; Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; 3 unilateral intranasal sprays per dose; Other Name: Kovacaine Mist
Experimental: Tetracaine Only, 3 sprays unilateral; Tetracaine HCl 3%	Drug: Tetracaine HCl 3%; 3 unilateral intranasal sprays per dose; Other Name: Active control
Placebo Comparator: Placebo, 3 sprays unilateral; Placebo	Drug: Placebo; 3 unilateral intranasal sprays per dose; Other Name: Inactive ingredients

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic. [ Time Frame: at 15 minutes with a 3 minute window ]
   If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

Secondary Outcome Measures :

1. Intraoral Soft-tissue Anesthesia (Yes/no) [ Time Frame: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window ]
   Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints
2. Number of Participants With a Heart Rate Higher Than 125 Bpm [ Time Frame: at any time within 120 minutes following drug administration ]
3. Number of Participants With a Heart Rate Lower Than 50 Bpm [ Time Frame: at any time within 120 minutes following drug administration ]
4. Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg [ Time Frame: at any time within 120 minutes following drug administration ]
5. Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg [ Time Frame: at any time within 120 minutes following drug administration ]
6. Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg [ Time Frame: at any time within 120 minutes following drug administration ]
7. Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg [ Time Frame: at any time within 120 minutes following drug administration ]
8. Absolute Maximum Change From Baseline in Heart Rate [ Time Frame: from baseline to 120 minutes following drug administration ]
9. Absolute Maximum Change From Baseline in Systolic Blood Pressure [ Time Frame: from baseline to 120 minutes following drug administration ]
10. Absolute Maximum Change From Baseline in Diastolic Blood Pressure [ Time Frame: from baseline to 120 minutes following drug administration ]
11. The Profile Over Time of Heart Rate [ Time Frame: from baseline to 120 minutes following drug administration ]
12. The Profile Over Time of Systolic Blood Pressure [ Time Frame: from baseline to 120 minutes following drug administration ]
13. The Profile Over Time of Diastolic Blood Pressure [ Time Frame: from baseline to 120 minutes following drug administration ]
14. Alcohol Sniff Test [ Time Frame: administered at baseline, 120 minutes and approximately 24 hours after drug administration ]
    The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.
15. Intraoral Soft-tissue Anesthesia (Onset and Duration) [ Time Frame: up to 120 mins post-dose ]
    Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

University of Buffalo

Buffalo, New York, United States, 14214-8004

United States, Utah

Family and Cosmetic Dentistry

Salt Lake City, Utah, United States, 84124

Jean Brown Research

Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

St. Renatus, LLC

Triligent International

Rho, Inc.

Investigators

• Study Director: Paul A. Moore, DMD/PhD/MPH; University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ciancio SG, Marberger AD, Ayoub F, Garlapo DA, Pantera EA Jr, Pantera CT, Al-Mubarak S, Sobieraj BD, He DY, Myneni SR. Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial. J Am Dent Assoc. 2016 May;147(5):339-347.e1. doi: 10.1016/j.adaj.2015.11.009. Epub 2016 Feb 15.

• Responsible Party: St. Renatus, LLC
• ClinicalTrials.gov Identifier: NCT01710787
• Other Study ID Numbers: SR 3-02
• First Posted: October 19, 2012
• Results First Posted: August 30, 2017
• Last Update Posted: August 30, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by St. Renatus, LLC:

operative; dental procedure

Additional relevant MeSH terms:

Phenylephrine; Oxymetazoline; Tetracaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Sympathomimetics; Autonomic Agents; Nasal Decongestants; Vasoconstrictor Agents; Respiratory System Agents; Cardiotonic Agents; Mydriatics; Adrenergic alpha-1 Receptor Agonists; Protective Agents