NCT03962634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

20 days

First QC Date

May 21, 2019

Results QC Date

October 7, 2020

Last Update Submit

November 13, 2020

Conditions

Caries,DentalApical Periodontitis

Keywords

Cavities

Outcome Measures

Primary Outcomes (1)

  • Success Rate of Pupal Anesthesia

    % dental procedures completed without the need for rescue anesthesia

    immediately after dental procedure, an average of 3 hours

Secondary Outcomes (6)

  • Spread of Anesthesia

    immediately after dental procedure, an average of 3 hours

  • Change in Anxiety Level

    from baseline to immediately after dental procedure

  • Anxiety

    immediately after dental procedure, an average of 3 hours

  • Change in Blood Pressure

    from baseline to immediately after dental procedure

  • Change in Heart Rate

    from baseline to immediately after dental procedure

  • +1 more secondary outcomes

Study Arms (2)

Kovanaze Nasal Spray (Pediatrics)

EXPERIMENTAL

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

Drug: Kovanaze Nasal Spray

Articaine Injections (Pediatrics)

ACTIVE COMPARATOR

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

Drug: Articaine Injection

Interventions

Kovanaze Nasal SprayDRUG

Intra-nasal local anesthetic

Also known as: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
Kovanaze Nasal Spray (Pediatrics)
Articaine InjectionDRUG

Local anesthetic

Also known as: Septocaine
Articaine Injections (Pediatrics)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
  • Adults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
  • Adults who require restorations in the maxillary teeth that would need local anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dental CariesPeriapical Periodontitis

Interventions

TetracaineOxymetazolineCarticaine

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiophenesSulfur Compounds

Results Point of Contact

Title
Parthasarathy Madurantakam
Organization
Virginia Commonwealth University
madurantakap@vcu.edu
804-828-4953

Study Officials

  • Parthasarathy Madurantakam, DDS, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 24, 2019

Study Start

August 28, 2019

Primary Completion

September 17, 2019

Study Completion

September 17, 2019

Last Updated

November 19, 2020

Results First Posted

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)