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

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ClinicalTrials.gov Identifier: NCT03962634
Recruitment Status : Suspended (Drug is not currently available, manufacturer does not expect new supply for 4 - 6 months.)
First Posted : May 24, 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. Even though success rates between 83 and 90 % have been reported for adults and children >40kg, [10] FDA label (Section 14.2) provides data for children (>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. [9]

  • One 0.1 mL spray for patients weighing 10 kg to less than 20 kg;
  • Two 0.1 mL sprays for 20 kg to less than 40 kg; or
  • Two 0.2 mL sprays for patients weighing 40 kg or more.

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 children (at least 6 years of age and weighing > 20 kg)
  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
Actual Study Start Date : August 28, 2019
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 (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
Drug: Kovanaze Nasal Spray
Intra-nasal local anesthetic
Other Name: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803‐100‐10

Active Comparator: Articaine Injections (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
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 ]
    STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.

  3. Anxiety [ Time Frame: immediately after dental procedure, an average of 3 hours ]
    Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)

  4. Change in Blood pressure [ Time Frame: from baseline to immediately after dental procedure ]
  5. Change in heart rate [ Time Frame: from baseline to immediately after dental procedure ]
  6. Change in pain [ Time Frame: from baseline to immediately after dental procedure ]
    Emoji scale ranging from 1 (very negative face) to 7 (very positive face)



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Ages Eligible for Study:   6 Years to 18 Years   (Child, 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

Additional Pediatric Inclusion Criteria:

  • Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

  • Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

  • 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.

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): NCT03962634


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: NCT03962634     History of Changes
Other Study ID Numbers: HM20014136 - pediatric
First Posted: May 24, 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:
Cavities
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