Trial Outcomes & Findings for Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia (NCT NCT01302483)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Continuous throughout dental treatment period (up to 60 minutes)

Results posted on

2015-06-17

Participant Flow

Recruitment completed within the month of December, 2008. Subjects were primarily recruited from University of Buffalo staff and students.

Participant milestones

Participant milestones
Measure	Kovacaine Nasal Spray .6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL	Lidocaine Injection 2% lidocaine HCL with 1:100,000 epinephrine
Overall Study STARTED	30	15
Overall Study COMPLETED	30	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kovacaine Nasal Spray n=30 Participants	Lidocaine Injection n=15 Participants	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	15 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	40.8 years STANDARD_DEVIATION 15.3 • n=7 Participants	39.3 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	15 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Continuous throughout dental treatment period (up to 60 minutes)

Population: Intention to treat

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.

Outcome measures

Outcome measures
Measure	Kovacaine Nasal Spray n=30 Participants Number of subjects able to complete the dental procedure without rescue	Lidocaine Injection n=15 Participants Number of subjects able to complete the dental procedure without rescue
Pulpal Anesthesia	25 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes

Population: Intention to treat

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)

Outcome measures

Outcome measures
Measure	Kovacaine Nasal Spray n=30 Participants Number of subjects able to complete the dental procedure without rescue	Lidocaine Injection n=15 Participants Number of subjects able to complete the dental procedure without rescue
Soft Tissue Anesthesia Duration Site 1 Duration	21.1 Minutes Standard Deviation 16.9	34.2 Minutes Standard Deviation 21.0
Soft Tissue Anesthesia Duration Site 2 Duration	16.1 Minutes Standard Deviation 16.9	32.1 Minutes Standard Deviation 4.9
Soft Tissue Anesthesia Duration Site 3 Duration	31.8 Minutes Standard Deviation 19.9	25.0 Minutes Standard Deviation 18.3
Soft Tissue Anesthesia Duration Site 4 Duration	31.4 Minutes Standard Deviation 24.1	29.3 Minutes Standard Deviation 27.6

SECONDARY outcome

Timeframe: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes

Population: Intention to treat

Maximum change from Baseline at any time point.

Outcome measures

Outcome measures
Measure	Kovacaine Nasal Spray n=30 Participants Number of subjects able to complete the dental procedure without rescue	Lidocaine Injection n=15 Participants Number of subjects able to complete the dental procedure without rescue
Maximum Change in Pulse From Baseline	-11.13 beats per minute Standard Deviation 9.68	-6.60 beats per minute Standard Deviation 15.58

SECONDARY outcome

Timeframe: Baseline, 15, 20, 30, 40 50, 60, 120 minutes

Population: Intention to treat

Maximum change from Baseline at any time point.

Outcome measures

Outcome measures
Measure	Kovacaine Nasal Spray n=30 Participants Number of subjects able to complete the dental procedure without rescue	Lidocaine Injection n=15 Participants Number of subjects able to complete the dental procedure without rescue
Maximum Change in Blood Pressure From Baseline Systolic blood pressure	4.50 mmHG Standard Deviation 17.39	3.43 mmHG Standard Deviation 10.62
Maximum Change in Blood Pressure From Baseline Diastolic blood pressure	-2.67 mmHG Standard Deviation 13.73	-5.07 mmHG Standard Deviation 8.49

SECONDARY outcome

Timeframe: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes

Population: Intent to Treat

Maximum change from Baseline at any time point

Outcome measures

Outcome measures
Measure	Kovacaine Nasal Spray n=30 Participants Number of subjects able to complete the dental procedure without rescue	Lidocaine Injection n=15 Participants Number of subjects able to complete the dental procedure without rescue
Maximum Change in Pulse Oximetry From Baseline	0.17 SpO2 Standard Deviation 2.39	-0.80 SpO2 Standard Deviation 2.76

Adverse Events

Kovacaine Nasal Spray

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Lidocaine Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Kovacaine Nasal Spray n=30 participants at risk .6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL	Lidocaine Injection n=15 participants at risk 2% lidocaine HCL with 1:100,000 epinephrine
Respiratory, thoracic and mediastinal disorders Nasal Congestion	20.0% 6/30 • 24 hours	0.00% 0/15 • 24 hours
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.3% 4/30 • 24 hours	0.00% 0/15 • 24 hours

Additional Information

Dr. Sebastian Ciancio

Department of Periodontics & Endodontics, School of Dental Medicine, University of Buffalo, SUNY

Phone: (716) 829-3848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place