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

2019-05-30 22:08:17 | BioPortfolio

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.

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. Even though success rates between 83 and 90 % have been reported for adults and children >40kg, [10] FDA label (Section 14.2) provides data for children (>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. [9]

- One 0.1 mL spray for patients weighing 10 kg to less than 20 kg;

- Two 0.1 mL sprays for 20 kg to less than 40 kg; or

- Two 0.2 mL sprays for patients weighing 40 kg or more.

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 different settings (procedures other than fillings and/or involving multiple teeth) in adults and children (at least 6 years of age and weighing > 20 kg)

2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

Study Design

Conditions

Caries,Dental

Intervention

Kovanaze Nasal Spray, Articaine Injection

Location

Virginia Commonwealth University
Richmond
Virginia
United States
23298

Status

Not yet recruiting

Source

Virginia Commonwealth University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-05-30T22:08:17-0400

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Medical and Biotech [MESH] Definitions

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Diagnostic tests conducted in order to measure the increment of active DENTAL CARIES over a period of time.

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Anesthesiology
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

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