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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Apical Periodontitis; Caries,Dental
• Intervention / Treatment: Drug: Kovanaze Nasal Spray; Drug: Articaine Injection

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

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kovanaze Nasal Spray (General Practice); Adults who require restorations in the maxillary teeth that would need local anesthesia	Drug: Kovanaze Nasal Spray; Intra-nasal local anesthetic; Other Names: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
Active Comparator: Articaine Injections (General Practice; Adults who require restorations in the maxillary teeth that would need local anesthesia	Drug: Articaine Injection; Local anesthetic; Other Names: Septocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of pupal anesthesia	% dental procedures completed without the need for rescue anesthesia	immediately after dental procedure, an average of 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spread of anesthesia	Number of teeth anesthetized in maxillary arch	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.	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	from baseline to immediately after dental procedure
Change in heart rate		from baseline to immediately after dental procedure
Change in pain	Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)	from baseline to immediately after dental procedure
Satisfaction with Kovanaze	8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze	immediately after dental procedure, an average of 3 hours
Number of post treatment anesthesia side effects	Phone survey asking about any side effects experienced from the anesthesia	24 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Parthasarathy Madurantakam, DDS, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2020
• Primary Completion (Estimated): September 1, 2021
• Study Completion (Estimated): October 1, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cavities, crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Dental Caries; Periapical Periodontitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline; Tetracaine; Carticaine
• Other Study ID Numbers: HM20014136 - adult general

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No