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A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults

<p><b>Problem</b>: Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist. An anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a &ldquo;shot,&rdquo; would greatly benefit dental patients. </p><p> <b>Methods</b>: The study employed a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth sufficient to allow completion of the Study Dental Procedure. A total of 36 subjects, randomized 2:1 (Kovacaine Mist: Placebo) were enrolled. </p><p> <b>Results</b>: Kovacaine Mist was significantly superior to placebo (p&lt;0.0001) with respect to the proportion of subjects who did not require rescue by injection of local anesthetic to complete the Study Dental Procedure. </p><p> <b>Conclusions</b>: Based of the results of this clinical trial, a nasal anesthetic, such as kovacaine mist, could potentially be used as a safe and effective alternative to maxillary infiltration for anesthetizing maxillary premolars and anteriors to achieve pulpal anesthesia. </p>

Identiferoai:union.ndltd.org:PROQUEST/oai:pqdtoai.proquest.com:1556924
Date18 July 2014
CreatorsSabti, Mohammad
PublisherUniversity of Maryland, Baltimore
Source SetsProQuest.com
LanguageEnglish
Detected LanguageEnglish
Typethesis

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