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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04104789
• Other study ID #: HM20014136 - adult general
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: October 2021

Study information

• Verified date: June 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Caries,Dental
• Dental Caries
• Periapical Periodontitis
• Periodontitis

Intervention

Drug:
• Kovanaze Nasal Spray
Intra-nasal local anesthetic
• Articaine Injection
Local anesthetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of pupal anesthesia	% dental procedures completed without the need for rescue anesthesia	immediately after dental procedure, an average of 3 hours
Secondary	Spread of anesthesia	Number of teeth anesthetized in maxillary arch	immediately after dental procedure, an average of 3 hours
Secondary	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
Secondary	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
Secondary	Change in heart rate		from baseline to immediately after dental procedure
Secondary	Change in pain	Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)	from baseline to immediately after dental procedure
Secondary	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
Secondary	Number of post treatment anesthesia side effects	Phone survey asking about any side effects experienced from the anesthesia	24 hours