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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Compare Kovanaze to conventional needle anesthetic in adults Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

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

Conditions
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Caries,Dental, Apical Periodontitis

Intervention / Treatment
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* Drug: Kovanaze Nasal Spray
* Drug: Articaine Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kovanaze Nasal Spray (General Practice)<br>Adults who require restorations in the maxillary teeth that would need local anesthesia | Drug: Kovanaze Nasal Spray<br>* Intra-nasal local anesthetic<br>* Other names: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10;|
| Active Comparator: Articaine Injections (General Practice<br>Adults who require restorations in the maxillary teeth that would need local anesthesia | Drug: Articaine Injection<br>* Local anesthetic<br>* Other names: Septocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of pupal anesthesia | % 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 | Number of teeth anesthetized in maxillary arch | immediately after dental procedure, an average of 3 hours | 
| 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 | 
| 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 | 
| Change in heart rate |  | from baseline to immediately after dental procedure | 
| Change in pain | Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm) | from baseline to immediately after dental procedure | 
| 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 | 
| Number of post treatment anesthesia side effects | Phone survey asking about any side effects experienced from the anesthesia | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cavities, crowns