Study Stopped
Manufacturer discontinued drug before any participants could be enrolled.
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJune 25, 2020
June 1, 2020
1 year
September 24, 2019
June 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate of pupal anesthesia
% dental procedures completed without the need for rescue anesthesia
immediately after dental procedure, an average of 3 hours
Secondary Outcomes (7)
Spread of anesthesia
immediately after dental procedure, an average of 3 hours
Change in Anxiety level
from baseline to immediately after dental procedure
Change in Blood pressure
from baseline to immediately after dental procedure
Change in heart rate
from baseline to immediately after dental procedure
Change in pain
from baseline to immediately after dental procedure
- +2 more secondary outcomes
Study Arms (2)
Kovanaze Nasal Spray (endodontics)
EXPERIMENTALAdults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
Articaine Injections (endodontics)
ACTIVE COMPARATORAdults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
Interventions
Intra-nasal local anesthetic
Eligibility Criteria
You may qualify if:
- 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 (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parthasarathy Madurantakam, DDS, PhD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2019
First Posted
September 26, 2019
Study Start
August 1, 2020
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share