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Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479517
First Posted: November 24, 2011
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rho, Inc.
Triligent International
Information provided by (Responsible Party):
St. Renatus, LLC
Results First Submitted: November 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Anesthesia
Interventions: Drug: Kovacaine Mist 0.1 mL x 4 sprays
Drug: Kovacaine Mist 0.2 mL x 2 sprays
Drug: Kovacaine Mist 0.2 mL x 1 spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Kovacaine Mist 0.1 mL x 4 Sprays

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.

Kovacaine Mist 0.2 mL x 2 Sprays

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.

Kovacaine Mist, 0.2 mL x 1 Spray

Total dose: 6 mg tetracaine/0.1 mg oxymetazoline

Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug


Participant Flow:   Overall Study
    Kovacaine Mist 0.1 mL x 4 Sprays   Kovacaine Mist 0.2 mL x 2 Sprays   Kovacaine Mist, 0.2 mL x 1 Spray
STARTED   10   10   10 
COMPLETED   10   10   10 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Kovacaine Mist 0.1 mL x 4 Sprays

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.

Kovacaine Mist 0.2 mL x 2 Sprays

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.

Kovacaine Mist, 0.2 mL x 1 Spray

Total dose: 6 mg tetracaine/0.1 mg oxymetazoline

Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug

Total Total of all reporting groups

Baseline Measures
   Kovacaine Mist 0.1 mL x 4 Sprays   Kovacaine Mist 0.2 mL x 2 Sprays   Kovacaine Mist, 0.2 mL x 1 Spray   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.5  (12.42)   58.6  (9.55)   54.0  (15.2)   54.7  (12.53) 
Gender 
[Units: Participants]
Count of Participants
       
Female      7  70.0%      6  60.0%      7  70.0%      20  66.7% 
Male      3  30.0%      4  40.0%      3  30.0%      10  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      10 100.0%      10 100.0%      10 100.0%      30 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      9  90.0%      10 100.0%      10 100.0%      29  96.7% 
More than one race      1  10.0%      0   0.0%      0   0.0%      1   3.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure   [ Time Frame: at 15 minutes, with +10 minute window ]

2.  Secondary:   The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.   [ Time Frame: 60 minutes ]

3.  Secondary:   The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.   [ Time Frame: 60 minutes ]

4.  Secondary:   Naris Examination   [ Time Frame: 60 minutes post drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christina Sletten, DDS
Organization: Rock Dental Clinic
phone: 719-599-9700



Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01479517     History of Changes
Other Study ID Numbers: SR 2-05
First Submitted: November 22, 2011
First Posted: November 24, 2011
Results First Submitted: November 2, 2016
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016