- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479517
Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth
November 2, 2016 updated by: St. Renatus, LLC
A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar).
Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts [four 100 μL, two 200 μL, or one 200 μL spray(s)] of 10 subjects each.
The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design.
Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl.
The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes.
The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart.
The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort.
Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80919
- Rock Dental Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects who are 18 years of age or older;
- requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia;
- having normal lip, nose, eyelid, and cheek sensations;
- able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol;
- having patency of naris on same side of head as tooth requiring the dental procedure.
Exclusion Criteria:
- Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease;
- inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy;
- having frequent nose bleeds (10 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, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens);
- history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past 3 weeks;
- are nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to take a urine pregnancy test on the day of but prior to study drug administration to rule out pregnancy);
- having used any investigational drug and/or participated in any clinical research trial within 30 days of baseline
- enlarged prostate
- narrow angle glaucoma
- use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of the study
- congenital or idiopathic methemoglobinemia
- diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kovacaine Mist 0.1 mL x 4 sprays
Total dose: 12 mg tetracaine/0.2
mg oxymetazoline
|
Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
Other Names:
|
Experimental: Kovacaine Mist 0.2 mL x 2 sprays
Total dose: 12 mg tetracaine/0.2
mg oxymetazoline
|
Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
Other Names:
|
Experimental: Kovacaine Mist, 0.2 mL x 1 spray
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
|
Dose = 1 intranasal spray of study drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure
Time Frame: at 15 minutes, with +10 minute window
|
at 15 minutes, with +10 minute window
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Time Frame: 60 minutes
|
60 minutes
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Time Frame: 60 minutes
|
60 minutes
|
|
Naris Examination
Time Frame: 60 minutes post drug administration
|
Number of patients with an abnormal naris examination finding.
|
60 minutes post drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Sletten, DDS, Rock Dental Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
November 23, 2011
First Posted (Estimate)
November 24, 2011
Study Record Updates
Last Update Posted (Estimate)
December 29, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SR 2-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Matthew BorzageRecruitingAnesthesia | Anesthesia; ReactionUnited States
Clinical Trials on Kovacaine Mist 0.1 mL x 4 sprays
-
Ixchelsis LimitedCompleted
-
Suzan A RattanAl-Kindy College of MedicineCompletedEndophthalmitis Postoperative
-
Marc TewfikCompleted