Trial Outcomes & Findings for Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth (NCT NCT01660893)

NCT ID: NCT01660893

Last Updated: 2017-09-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 26 participants
• Primary outcome timeframe: at 15 minutes with a 3 minute window
• Results posted on: 2017-09-05

Participant Flow

Participant milestones

Measure	Kovacaine Mist, 3 Sprays Unilateral Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral Placebo Placebo: 3 unilateral intranasal sprays per dose
Overall Study STARTED	10	10	6
Overall Study COMPLETED	10	10	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose	Total n=26 Participants Total of all reporting groups
Age, Continuous	31.3 years STANDARD_DEVIATION 10.22 • n=5 Participants	33.3 years STANDARD_DEVIATION 11.10 • n=7 Participants	32.7 years STANDARD_DEVIATION 9.85 • n=5 Participants	32.4 years STANDARD_DEVIATION 10.11 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	6 participants n=5 Participants	26 participants n=4 Participants

PRIMARY outcome

Timeframe: at 15 minutes with a 3 minute window

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). Success	5 Participants	2 Participants	0 Participants
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). Failure	5 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: at 15 minutes with a 3 minute window

Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Intraoral Soft-tissue Anesthesia (Yes/no) Incisive Papilla	7 Participants	5 Participants	2 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) Greater Palatine Foramen	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With Heart Rate Higher Than 125 Bpm	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With Heart Rate Lower Than 50 Bpm	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
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 90 mm Hg	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Systolic Blood Pressure	12.8 mmHg Standard Deviation 6.05	3.5 mmHg Standard Deviation 8.34	1.2 mmHg Standard Deviation 7.25
Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Diastolic Blood Pressure	11.2 mmHg Standard Deviation 5.35	4.5 mmHg Standard Deviation 4.12	6.2 mmHg Standard Deviation 8.84

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Heart Rate 45 Minutes	69.6 bpm Standard Deviation 8.65	64.3 bpm Standard Deviation 5.70	73.8 bpm Standard Deviation 8.30
The Profile Over Time of Heart Rate Pre-Study	76.9 bpm Standard Deviation 9.07	69.1 bpm Standard Deviation 7.95	81.0 bpm Standard Deviation 8.10
The Profile Over Time of Heart Rate 10 Minutes	69.6 bpm Standard Deviation 8.3	67.1 bpm Standard Deviation 7.03	75.8 bpm Standard Deviation 8.61
The Profile Over Time of Heart Rate 30 Minutes	64.6 bpm Standard Deviation 9.48	64.5 bpm Standard Deviation 6.36	NA bpm Standard Deviation NA Data was not collected as study dental procedure was still ongoing
The Profile Over Time of Heart Rate 60 Minutes	67.3 bpm Standard Deviation 11.34	65.3 bpm Standard Deviation 8.31	70.2 bpm Standard Deviation 5.04
The Profile Over Time of Heart Rate 90 Minutes	67.1 bpm Standard Deviation 7.74	64.3 bpm Standard Deviation 8.39	72.0 bpm Standard Deviation 7.56
The Profile Over Time of Heart Rate 120 Minutes	68.4 bpm Standard Deviation 6.31	65.0 bpm Standard Deviation 8.43	70.8 bpm Standard Deviation 7.57

SECONDARY outcome

Timeframe: administered at approximately 24 hours after drug administration

The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Alcohol Sniff Test	0.4 cm Standard Deviation 5.44	0.8 cm Standard Deviation 7.69	2.1 cm Standard Deviation 2.94

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Systolic Blood Pressure Pre-Study	113.0 mmHg Standard Deviation 8.23	116.1 mmHg Standard Deviation 11.0	125.5 mmHg Standard Deviation 6.19
The Profile Over Time of Systolic Blood Pressure 10 Minutes	116.5 mmHg Standard Deviation 6.82	114.2 mmHg Standard Deviation 5.51	118.8 mmHg Standard Deviation 8.77
The Profile Over Time of Systolic Blood Pressure 30 Minutes	123.0 mmHg Standard Deviation 11.34	110.0 mmHg Standard Deviation 4.24	NA mmHg Standard Deviation NA Data was not collected as study dental procedure was still ongoing
The Profile Over Time of Systolic Blood Pressure 45 Minutes	118.5 mmHg Standard Deviation 9.26	113.6 mmHg Standard Deviation 9.31	118.8 mmHg Standard Deviation 10.44
The Profile Over Time of Systolic Blood Pressure 60 Minutes	116.1 mmHg Standard Deviation 9.68	113.3 mmHg Standard Deviation 7.27	121.7 mmHg Standard Deviation 12.39
The Profile Over Time of Systolic Blood Pressure 90 Minutes	117.7 mmHg Standard Deviation 8.34	112.0 mmHg Standard Deviation 6.93	119.7 mmHg Standard Deviation 8.89
The Profile Over Time of Systolic Blood Pressure 120 Minutes	119.5 mmHg Standard Deviation 10.89	113.7 mmHg Standard Deviation 9.31	119.2 mmHg Standard Deviation 9.50

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Diastolic Blood Pressure Pre-Study	74.1 mmHg Standard Deviation 5.09	73.0 mmHg Standard Deviation 7.09	77.7 mmHg Standard Deviation 7.17
The Profile Over Time of Diastolic Blood Pressure 10 Minutes	77.9 mmHg Standard Deviation 7.06	73.8 mmHg Standard Deviation 5.65	75.5 mmHg Standard Deviation 4.23
The Profile Over Time of Diastolic Blood Pressure 30 Minutes	81.0 mmHg Standard Deviation 6.96	70.0 mmHg Standard Deviation 1.41	NA mmHg Standard Deviation NA Data was not collected as study dental procedure was still ongoing
The Profile Over Time of Diastolic Blood Pressure 45 Minutes	76.4 mmHg Standard Deviation 5.8	72.2 mmHg Standard Deviation 6.03	74.2 mmHg Standard Deviation 7.81
The Profile Over Time of Diastolic Blood Pressure 60 Minutes	76.1 mmHg Standard Deviation 6.62	75.9 mmHg Standard Deviation 6.52	77.8 mmHg Standard Deviation 7.68
The Profile Over Time of Diastolic Blood Pressure 90 Minutes	80.5 mmHg Standard Deviation 8.78	73.1 mmHg Standard Deviation 6.40	78.8 mmHg Standard Deviation 7.28
The Profile Over Time of Diastolic Blood Pressure 120 Minutes	79.1 mmHg Standard Deviation 10.91	72.1 mmHg Standard Deviation 8.13	77.7 mmHg Standard Deviation 8.55

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Absolute Maximum Change From Baseline in Heart Rate	3.4 bpm Standard Deviation 8.62	3.5 bpm Standard Deviation 7.09	2.3 bpm Standard Deviation 7.55

Adverse Events

Kovacaine Mist, 3 Sprays Unilateral

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Tetracaine Only, 3 Sprays Unilateral

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo, 3 Sprays Unilateral

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Kovacaine Mist, 3 Sprays Unilateral n=10 participants at risk Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=10 participants at risk Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=6 participants at risk Placebo Placebo: 3 unilateral intranasal sprays per dose
Gastrointestinal disorders Oral discomfort	20.0% 2/10 • 24 hours	0.00% 0/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Nasal congestion	80.0% 8/10 • 24 hours	70.0% 7/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Rhinorrhea	60.0% 6/10 • 24 hours	30.0% 3/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	40.0% 4/10 • 24 hours	10.0% 1/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Nasal discomfort	30.0% 3/10 • 24 hours	20.0% 2/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/10 • 24 hours	10.0% 1/10 • 24 hours	16.7% 1/6 • 24 hours
Nervous system disorders Dysgeusia	20.0% 2/10 • 24 hours	0.00% 0/10 • 24 hours	0.00% 0/6 • 24 hours
Nervous system disorders Headache	10.0% 1/10 • 24 hours	20.0% 2/10 • 24 hours	33.3% 2/6 • 24 hours
Nervous system disorders Dizziness	10.0% 1/10 • 24 hours	0.00% 0/10 • 24 hours	16.7% 1/6 • 24 hours
Eye disorders Lacrimation increased	30.0% 3/10 • 24 hours	20.0% 2/10 • 24 hours	0.00% 0/6 • 24 hours
Eye disorders Vision blurred	20.0% 2/10 • 24 hours	0.00% 0/10 • 24 hours	0.00% 0/6 • 24 hours
Eye disorders Hypoaesthesia eye	10.0% 1/10 • 24 hours	10.0% 1/10 • 24 hours	0.00% 0/6 • 24 hours
Ear and labyrinth disorders Ear discomfort	10.0% 1/10 • 24 hours	10.0% 1/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Pharyngeal Hypoaesthesia	40.0% 4/10 • 24 hours	20.0% 2/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Sneezing	20.0% 2/10 • 24 hours	0.00% 0/10 • 24 hours	0.00% 0/6 • 24 hours
Respiratory, thoracic and mediastinal disorders Intranasal Hypoaesthesia	10.0% 1/10 • 24 hours	30.0% 3/10 • 24 hours	16.7% 1/6 • 24 hours
Injury, poisoning and procedural complications Anaesthetic Complication	0.00% 0/10 • 24 hours	10.0% 1/10 • 24 hours	16.7% 1/6 • 24 hours

Additional Information

Dr. Sharon M. Gordon

University of Maryland

Phone: 410-706-1656

Email: sgordon@dental.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place