Clinical trial NCT04104789: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Caries,Dental
Apical Periodontitis
Keywords: Cavities, crowns
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Compare Kovanaze to conventional needle anesthetic in adults
2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

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.

Primary outcomes:
measure: Success rate of pupal anesthesia
timeFrame: immediately after dental procedure, an average of 3 hours
Secondary outcomes:
measure: Spread of anesthesia
timeFrame: immediately after dental procedure, an average of 3 hours
measure: Change in Anxiety level
timeFrame: from baseline to immediately after dental procedure
measure: Change in Blood pressure
timeFrame: from baseline to immediately after dental procedure
measure: Change in heart rate
timeFrame: from baseline to immediately after dental procedure
measure: Change in pain
timeFrame: from baseline to immediately after dental procedure
measure: Satisfaction with Kovanaze
timeFrame: immediately after dental procedure, an average of 3 hours
measure: Number of post treatment anesthesia side effects
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Parthasarathy Madurantakam, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: