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

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 2

Conditions: Apical Periodontitis; Caries,Dental

Treatments: Drug: Articaine Injection; Drug: Kovanaze Nasal Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04104789

HM20014136 - adult general

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Kovanaze Nasal Spray (General Practice)

Experimental group

Description:

Adults who require restorations in the maxillary teeth that would need local anesthesia

Treatment:

Drug: Kovanaze Nasal Spray

Articaine Injections (General Practice

Active Comparator group

Description:

Adults who require restorations in the maxillary teeth that would need local anesthesia

Treatment:

Drug: Articaine Injection