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

NCT04104789 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HM20014136 - adult general
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries,Dental; Apical Periodontitis

Keywords

Cavities, crowns

Outcome Measures

Primary Outcomes (1)

• Success rate of pupal anesthesia

  % dental procedures completed without the need for rescue anesthesia

  immediately after dental procedure, an average of 3 hours

Secondary Outcomes (7)

• Spread of anesthesia

  immediately after dental procedure, an average of 3 hours

• Change in Anxiety level

  from baseline to immediately after dental procedure

• Change in Blood pressure

  from baseline to immediately after dental procedure

• Change in heart rate

  from baseline to immediately after dental procedure

• Change in pain

  from baseline to immediately after dental procedure

Study Arms (2)

Kovanaze Nasal Spray (General Practice)

EXPERIMENTAL

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

Drug: Kovanaze Nasal Spray

Articaine Injections (General Practice

ACTIVE COMPARATOR

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

Drug: Articaine Injection

Interventions

Kovanaze Nasal Spray DRUG

Intra-nasal local anesthetic

Also known as: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10

Kovanaze Nasal Spray (General Practice)

Articaine Injection DRUG

Local anesthetic

Also known as: Septocaine

Articaine Injections (General Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

MeSH Terms

Conditions

Dental Caries; Periapical Periodontitis

Interventions

Tetracaine; Oxymetazoline; Carticaine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds

Study Officials

• Parthasarathy Madurantakam, DDS, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share