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

Primary Purpose

Caries,Dental, Apical Periodontitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kovanaze Nasal Spray
Articaine Injection
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries,Dental focused on measuring Cavities, crowns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Kovanaze Nasal Spray (General Practice)

    Articaine Injections (General Practice

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Success rate of pupal anesthesia
    % dental procedures completed without the need for rescue anesthesia

    Secondary Outcome Measures

    Spread of anesthesia
    Number of teeth anesthetized in maxillary arch
    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.
    Change in Blood pressure
    systolic and diastolic blood pressure will be assessed before and after the dental procedure
    Change in heart rate
    Change in pain
    Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
    Satisfaction with Kovanaze
    8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
    Number of post treatment anesthesia side effects
    Phone survey asking about any side effects experienced from the anesthesia

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    June 22, 2020
    Sponsor
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04104789
    Brief Title
    Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
    Official Title
    Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Manufacture of drug discontinued before any participants could be enrolled.
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries,Dental, Apical Periodontitis
    Keywords
    Cavities, crowns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kovanaze Nasal Spray (General Practice)
    Arm Type
    Experimental
    Arm Description
    Adults who require restorations in the maxillary teeth that would need local anesthesia
    Arm Title
    Articaine Injections (General Practice
    Arm Type
    Active Comparator
    Arm Description
    Adults who require restorations in the maxillary teeth that would need local anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Kovanaze Nasal Spray
    Other Intervention Name(s)
    Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
    Intervention Description
    Intra-nasal local anesthetic
    Intervention Type
    Drug
    Intervention Name(s)
    Articaine Injection
    Other Intervention Name(s)
    Septocaine
    Intervention Description
    Local anesthetic
    Primary Outcome Measure Information:
    Title
    Success rate of pupal anesthesia
    Description
    % dental procedures completed without the need for rescue anesthesia
    Time Frame
    immediately after dental procedure, an average of 3 hours
    Secondary Outcome Measure Information:
    Title
    Spread of anesthesia
    Description
    Number of teeth anesthetized in maxillary arch
    Time Frame
    immediately after dental procedure, an average of 3 hours
    Title
    Change in Anxiety level
    Description
    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.
    Time Frame
    from baseline to immediately after dental procedure
    Title
    Change in Blood pressure
    Description
    systolic and diastolic blood pressure will be assessed before and after the dental procedure
    Time Frame
    from baseline to immediately after dental procedure
    Title
    Change in heart rate
    Time Frame
    from baseline to immediately after dental procedure
    Title
    Change in pain
    Description
    Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
    Time Frame
    from baseline to immediately after dental procedure
    Title
    Satisfaction with Kovanaze
    Description
    8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
    Time Frame
    immediately after dental procedure, an average of 3 hours
    Title
    Number of post treatment anesthesia side effects
    Description
    Phone survey asking about any side effects experienced from the anesthesia
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Parthasarathy Madurantakam, DDS, PhD
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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