Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Anesthesia
In brief
To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist administered unilaterally with respect to global profound pulpal anesthesia in target teeth numbers 4-13.
Key facts
- Study ID
- NCT02457806
- Run by
- St. Renatus, LLC
- People needed
- 48
- Starts
- 2011-08-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2016-11-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female 18 years of age or older.
- Eight representative maxillary teeth [(3 (or 2), 4 (or 5), 6, 8, 9, 11, 13 (or 12), and 14 (or15)] free of observable decay (or other pathology), crowns or veneers, all of which have EPT values of 10-50 at screening.
- Normal lip, nose, eyelid, palate, and cheek sensation.
- Patency of both left and right nasal airways.
- Ability to understand and willingness to sign the study informed consent form, communicate with study investigators, and understand and comply with the requirements of the study protocol.
You may not qualify if…
- Poorly controlled hypertension (blood pressure greater than 150/90 mmHg) or history of coronary heart disease.
- Diabetes mellitus.
- Any active thyroid disease other than S/P thyroidectomy on thyroid hormone replacement with TSH values in the normal range.
- History or presence of narrow-angle glaucoma.
- Prostatic enlargement.
- History of sinus/nasal surgery that, in the opinion of the investigator, could confound study results.
- History of frequent nose bleeds.
- Receipt of 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, succinylcholine, or para-aminobenzoic acid (as found in PABA-containing sunscreens).
- History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite antioxidants.
- History of drug abuse.
- Use of a monoamine oxidase inhibitor within the 3 weeks immediately prior to anticipated study participation.
- Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to undergo pregnancy testing to rule out pregnancy)
- Use of any investigational drug and/or participation in a clinical research trial within 30 days of the first study dosing day.
- Requirement for uninterrupted use of any medication with actions that might, in the opinion of the involved investigator, confound interpretation of study results.
Where it is running
- Jean Brown Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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