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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105985
Recruitment Status : Suspended (Drug is not currently available, manufacturer does not expect new supply for 4 - 6 months.)
First Posted : September 26, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Caries,Dental Apical Periodontitis Drug: Kovanaze Nasal Spray Drug: Articaine Injection Phase 2

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:

  1. Compare Kovanaze to conventional needle anesthetic for procedures other than fillings and/or involving multiple teeth in adults
  2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kovanaze Nasal Spray (endodontics)
Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
Drug: Kovanaze Nasal Spray
Intra-nasal local anesthetic
Other Name: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803‐100‐10

Active Comparator: Articaine Injections (endodontics)
Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
Drug: Articaine Injection
Local anesthetic
Other Name: Septocaine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Spread of anesthesia [ Time Frame: immediately after dental procedure, an average of 3 hours ]
    Number of teeth anesthetized in maxillary arch

  2. 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.

  3. Change in Blood pressure [ Time Frame: from baseline to immediately after dental procedure ]
  4. Change in heart rate [ Time Frame: from baseline to immediately after dental procedure ]
  5. 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)

  6. 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

  7. Number of post treatment anesthesia side effects [ Time Frame: 24 hours ]
    Phone survey asking about any side effects experienced from the anesthesia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (>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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105985


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Parthasarathy Madurantakam, DDS, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04105985    
Other Study ID Numbers: HM20014136 - adult endodontics
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Virginia Commonwealth University:
Necrotic teeth, root canals
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Dental Caries
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases
Tooth Demineralization
Tooth Diseases
Oxymetazoline
Tetracaine
Carticaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents