Status:
WITHDRAWN
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Caries,Dental
Apical Periodontitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Kovanaz...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04104789
Start Date
September 1 2020
End Date
October 1 2021
Last Update
October 15 2024
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