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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03962634
• Other study ID #: HM20014136 - pediatric
• Status: Terminated
• Phase: Phase 2
• Start date: August 28, 2019
• Est. completion date: September 17, 2019

Study information

• Verified date: November 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. [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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

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

Additional Pediatric Inclusion Criteria:

• Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

• Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

• 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
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

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	STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.	from baseline to immediately after dental procedure
Secondary	Anxiety	Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)	immediately after dental procedure, an average of 3 hours
Secondary	Change in Blood Pressure		from baseline to immediately after dental procedure
Secondary	Change in Heart Rate		from baseline to immediately after dental procedure
Secondary	Change in Pain	Emoji scale ranging from 1 (very negative face) to 7 (very positive face)	from baseline to immediately after dental procedure