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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04104789

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental Apical Periodontitis	Drug: Kovanaze Nasal Spray Drug: Articaine Injection	Phase 2

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Success rate of pupal anesthesia [immediately after dental procedure, an average of 3 hours]
% dental procedures completed without the need for rescue anesthesia

Secondary Outcome Measures

Spread of anesthesia [immediately after dental procedure, an average of 3 hours]
Number of teeth anesthetized in maxillary arch
Change in Anxiety level [from baseline to immediately after dental procedure]
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.
Change in Blood pressure [from baseline to immediately after dental procedure]
systolic and diastolic blood pressure will be assessed before and after the dental procedure
Change in heart rate [from baseline to immediately after dental procedure]
Change in pain [from baseline to immediately after dental procedure]
Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
Satisfaction with Kovanaze [immediately after dental procedure, an average of 3 hours]
8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
Number of post treatment anesthesia side effects [24 hours]
Phone survey asking about any side effects experienced from the anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.