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

Phase 3 Completed 110 enrolled St. Renatus, LLC Rho, Inc. · collab Triligent International · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2012-10
Primary completion: 2013-02
Completion: 2013-02

Outcome

Met primary endpoint

paper P < .001 for K305 versus tetracaine only and versus placebo). PMID 26892312 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxymetazoline	Other / unclassified	0.05 %	Intranasal
Subject	tetracaine	Other / unclassified	3 %	Intranasal

Indications

No indication recorded.