Phase 2
N=30
Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01479517 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure — 10; 7; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Kovacaine Mist 0.1 mL x 4 sprays (Drug); Kovacaine Mist 0.2 mL x 2 sprays (Drug); Kovacaine Mist 0.2 mL x 1 spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Renatus, LLC
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure |
10; 7; 8 | — |
| SECONDARY The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values. |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed. |
6; 5; 3; 9; 5; 5 | — |
| SECONDARY Naris Examination |
0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01479517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.