- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105985
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
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 for procedures other than fillings and/or involving multiple teeth in adults
- Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Kovanaze Nasal Spray (endodontics)
Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
|
Intra-nasal local anesthetic
Other Names:
|
ACTIVE_COMPARATOR: Articaine Injections (endodontics)
Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
|
Local anesthetic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of pupal anesthesia
Time Frame: immediately after dental procedure, an average of 3 hours
|
% dental procedures completed without the need for rescue anesthesia
|
immediately after dental procedure, an average of 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spread of anesthesia
Time Frame: immediately after dental procedure, an average of 3 hours
|
Number of teeth anesthetized in maxillary arch
|
immediately after dental procedure, an average of 3 hours
|
Change in Anxiety level
Time Frame: 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.
|
from baseline to immediately after dental procedure
|
Change in heart rate
Time Frame: from baseline to immediately after dental procedure
|
from baseline to immediately after dental procedure
|
|
Change in pain
Time Frame: from baseline to immediately after dental procedure
|
Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
|
from baseline to immediately after dental procedure
|
Satisfaction with Kovanaze
Time Frame: immediately after dental procedure, an average of 3 hours
|
8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
|
immediately after dental procedure, an average of 3 hours
|
Number of post treatment anesthesia side effects
Time Frame: 24 hours
|
Phone survey asking about any side effects experienced from the anesthesia
|
24 hours
|
Change in Blood pressure
Time Frame: from baseline to immediately after dental procedure
|
from baseline to immediately after dental procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Tooth Demineralization
- Tooth Diseases
- Jaw Diseases
- Periapical Diseases
- Periodontitis
- Dental Caries
- Periapical Periodontitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Oxymetazoline
- Tetracaine
- Carticaine
Other Study ID Numbers
- HM20014136 - adult endodontics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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