NCT01710787

Brief Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

August 30, 2017

Completed
Last Updated

August 30, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

October 17, 2012

Results QC Date

October 6, 2016

Last Update Submit

July 28, 2017

Conditions

Anesthesia

Keywords

operativedental procedure

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.

    If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

    at 15 minutes with a 3 minute window

Secondary Outcomes (15)

  • Intraoral Soft-tissue Anesthesia (Yes/no)

    at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window

  • Number of Participants With a Heart Rate Higher Than 125 Bpm

    at any time within 120 minutes following drug administration

  • Number of Participants With a Heart Rate Lower Than 50 Bpm

    at any time within 120 minutes following drug administration

  • Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg

    at any time within 120 minutes following drug administration

  • Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg

    at any time within 120 minutes following drug administration

  • +10 more secondary outcomes

Study Arms (3)

Kovacaine Mist, 3 sprays unilateral

EXPERIMENTAL

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Tetracaine Only, 3 sprays unilateral

EXPERIMENTAL

Tetracaine HCl 3%

Drug: Tetracaine HCl 3%

Placebo, 3 sprays unilateral

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%DRUG

3 unilateral intranasal sprays per dose

Also known as: Kovacaine Mist
Kovacaine Mist, 3 sprays unilateral
Tetracaine HCl 3%DRUG

3 unilateral intranasal sprays per dose

Also known as: Active control
Tetracaine Only, 3 sprays unilateral
PlaceboDRUG

3 unilateral intranasal sprays per dose

Also known as: Inactive ingredients
Placebo, 3 sprays unilateral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18 years of age or older.
  • Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
  • Normal lip, nose, eyelid, and cheek sensation.
  • Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
  • Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
  • Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
  • Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

You may not qualify if:

  • Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
  • Inadequately controlled active thyroid disease of any type.
  • Frequent nose bleeds (≥ 5 per month).
  • Having received dental care requiring a local anesthetic within the last 24 hours.
  • History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
  • History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
  • Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
  • Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
  • Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
  • Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
  • History of congenital or idiopathic methemoglobinemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Buffalo

Buffalo, New York, 14214-8004, United States

Location

Family and Cosmetic Dentistry

Salt Lake City, Utah, 84124, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

  • Ciancio SG, Marberger AD, Ayoub F, Garlapo DA, Pantera EA Jr, Pantera CT, Al-Mubarak S, Sobieraj BD, He DY, Myneni SR. Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial. J Am Dent Assoc. 2016 May;147(5):339-347.e1. doi: 10.1016/j.adaj.2015.11.009. Epub 2016 Feb 15.

    PMID: 26892312DERIVED

MeSH Terms

Interventions

Tetracaine

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Adam D. Marberger, DDS
Organization
Jean Brown Research
801-261-2000

Study Officials

  • Paul A. Moore, DMD/PhD/MPH

    University of Pittsburgh

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 30, 2017

Results First Posted

August 30, 2017

Record last verified: 2017-07

Locations

US(3)