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

Primary Purpose

Caries,Dental, Apical Periodontitis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Kovanaze Nasal Spray

Articaine Injection

About this trial

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

Eligibility Criteria

6 Years - 18 Years (Child, 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

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.

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kovanaze Nasal Spray (Pediatrics)

Articaine Injections (Pediatrics)

Arm Description

Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth

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

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

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.

Anxiety

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)

Change in Blood Pressure

Change in Heart Rate

Change in Pain

Emoji scale ranging from 1 (very negative face) to 7 (very positive face)

Full Information

NCT ID

NCT03962634

First Posted

May 21, 2019

Last Updated

November 13, 2020

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT03962634

Brief Title

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

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

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Drug is no longer being manufactured

Study Start Date

August 28, 2019 (Actual)

Primary Completion Date

September 17, 2019 (Actual)

Study Completion Date

September 17, 2019 (Actual)

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

Product Manufactured in and Exported from the U.S.

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. [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: Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg) 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kovanaze Nasal Spray (Pediatrics)

Arm Type

Experimental

Arm Description

Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth

Arm Title

Articaine Injections (Pediatrics)

Arm Type

Active Comparator

Arm Description

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

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

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.

Time Frame

from baseline to immediately after dental procedure

Title

Anxiety

Description

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)

Time Frame

immediately after dental procedure, an average of 3 hours

Title

Change in Blood Pressure

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

Emoji scale ranging from 1 (very negative face) to 7 (very positive face)

Time Frame

from baseline to immediately after dental procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parthasarathy Madurantakam, DDS, PhD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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