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

Virginia Commonwealth University

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Caries,Dental Apical Periodontitis

Interventions

Kovanaze Nasal SprayDRUG

Intra-nasal local anesthetic

Articaine InjectionDRUG

Local anesthetic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Success rate of pupal anesthesia

% dental procedures completed without the need for rescue anesthesia

Time frame: immediately after dental procedure, an average of 3 hours

Secondary Outcomes

Spread of anesthesia

Number of teeth anesthetized in maxillary arch

Time frame: immediately after dental procedure, an average of 3 hours

Change in Anxiety level

Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25.

Time frame: from baseline to immediately after dental procedure

Change in Blood pressure

systolic and diastolic blood pressure will be assessed before and after the dental procedure

Time frame: from baseline to immediately after dental procedure

Change in heart rate

Time frame: from baseline to immediately after dental procedure

Change in pain

Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)

Time frame: from baseline to immediately after dental procedure

Satisfaction with Kovanaze

8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze

Time frame: immediately after dental procedure, an average of 3 hours

Number of post treatment anesthesia side effects

Data from ClinicalTrials.gov

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