Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Anesthesia

In brief

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.

Key facts

Study ID

NCT01660893

Run by

St. Renatus, LLC

People needed

26

Starts

2012-08-01

Expected to finish

2012-09-01

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Family and Cosmetic Dentistry — Salt Lake City, Utah, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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