NCT04105985

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. \[9\] 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 for procedures other than fillings and/or involving multiple teeth in adults 2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

Conditions

• Caries,Dental
• Apical Periodontitis

Interventions

Type	Name	Description
DRUG	Kovanaze Nasal Spray	Intra-nasal local anesthetic
DRUG	Articaine Injection	Local anesthetic

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2019-09-26
• Last updated: 2020-06-25

Regulatory

• FDA-regulated drug study