Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Dental Anesthesia Efficacy Clinical Trial

Official title:

A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302483
• Other study ID #: SR 2-01
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: June 16, 2015
• Start date: December 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2015
• Source: St. Renatus, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dental Anesthesia Efficacy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
St. Renatus, LLC	Ground Zero Pharmaceuticals, Rho, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Soft Tissue Anesthesia Duration	Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were: Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule; Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule; Site 3: Incisive papilla; Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)	Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes	No
Secondary	Maximum Change in Pulse From Baseline	Maximum change from Baseline at any time point.	Baseline, 15, 20, 30, 40, 50, 60, 120 minutes	Yes
Secondary	Maximum Change in Blood Pressure From Baseline	Maximum change from Baseline at any time point.	Baseline, 15, 20, 30, 40 50, 60, 120 minutes	Yes
Secondary	Maximum Change in Pulse Oximetry From Baseline	Maximum change from Baseline at any time point	Baseline, 15, 20, 30, 40, 50, 60, 120 minutes	Yes