Back to resultsKovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
Primary Purpose
Caries,Dental, Apical Periodontitis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kovanaze Nasal Spray
Articaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Caries,Dental focused on measuring Cavities, crowns
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists Class I or II
- Preoperative heart rate of 55 to 100 beats per minute
- Maximum blood pressure reading of 166/100 mmHg
- Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
- Adults who require restorations in the maxillary teeth that would need local anesthesia
Exclusion Criteria:
- Inadequately controlled thyroid disease
- Five or more nosebleeds in the past month
- Known allergy to any study drug or para-aminobenzoic acid
- History of methemoglobinemia
- Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
- Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kovanaze Nasal Spray (General Practice)
Articaine Injections (General Practice
Arm Description
Adults who require restorations in the maxillary teeth that would need local anesthesia
Adults who require restorations in the maxillary teeth that would need local anesthesia
Outcomes
Primary Outcome Measures
Success rate of pupal anesthesia
% dental procedures completed without the need for rescue anesthesia
Secondary Outcome Measures
Spread of anesthesia
Number of teeth anesthetized in maxillary arch
Change in Anxiety level
Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25.
Change in Blood pressure
systolic and diastolic blood pressure will be assessed before and after the dental procedure
Change in heart rate
Change in pain
Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
Satisfaction with Kovanaze
8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
Number of post treatment anesthesia side effects
Phone survey asking about any side effects experienced from the anesthesia
Full Information
NCT ID
NCT04104789
First Posted
September 24, 2019
Last Updated
June 22, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04104789
Brief Title
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
Official Title
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Manufacture of drug discontinued before any participants could be enrolled.
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
Detailed Description
In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face.
With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:
Compare Kovanaze to conventional needle anesthetic in adults
Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental, Apical Periodontitis
Keywords
Cavities, crowns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kovanaze Nasal Spray (General Practice)
Arm Type
Experimental
Arm Description
Adults who require restorations in the maxillary teeth that would need local anesthesia
Arm Title
Articaine Injections (General Practice
Arm Type
Active Comparator
Arm Description
Adults who require restorations in the maxillary teeth that would need local anesthesia
Intervention Type
Drug
Intervention Name(s)
Kovanaze Nasal Spray
Other Intervention Name(s)
Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
Intervention Description
Intra-nasal local anesthetic
Intervention Type
Drug
Intervention Name(s)
Articaine Injection
Other Intervention Name(s)
Septocaine
Intervention Description
Local anesthetic
Primary Outcome Measure Information:
Title
Success rate of pupal anesthesia
Description
% dental procedures completed without the need for rescue anesthesia
Time Frame
immediately after dental procedure, an average of 3 hours
Secondary Outcome Measure Information:
Title
Spread of anesthesia
Description
Number of teeth anesthetized in maxillary arch
Time Frame
immediately after dental procedure, an average of 3 hours
Title
Change in Anxiety level
Description
Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25.
Time Frame
from baseline to immediately after dental procedure
Title
Change in Blood pressure
Description
systolic and diastolic blood pressure will be assessed before and after the dental procedure
Time Frame
from baseline to immediately after dental procedure
Title
Change in heart rate
Time Frame
from baseline to immediately after dental procedure
Title
Change in pain
Description
Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
Time Frame
from baseline to immediately after dental procedure
Title
Satisfaction with Kovanaze
Description
8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
Time Frame
immediately after dental procedure, an average of 3 hours
Title
Number of post treatment anesthesia side effects
Description
Phone survey asking about any side effects experienced from the anesthesia
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists Class I or II
Preoperative heart rate of 55 to 100 beats per minute
Maximum blood pressure reading of 166/100 mmHg
Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
Adults who require restorations in the maxillary teeth that would need local anesthesia
Exclusion Criteria:
Inadequately controlled thyroid disease
Five or more nosebleeds in the past month
Known allergy to any study drug or para-aminobenzoic acid
History of methemoglobinemia
Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parthasarathy Madurantakam, DDS, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
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