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Dissertation/Thesis Abstract

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
by Sabti, Mohammad, M.S., University of Maryland, Baltimore, 2014, 37; 1556924
Abstract (Summary)

Problem: 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 “shot,” would greatly benefit dental patients.

Methods: 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.

Results: Kovacaine Mist was significantly superior to placebo (p<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.

Conclusions: 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.

Indexing (document details)
Advisor: Gordon, Sharon M.
Commitee: Barnes, Douglas, Bloom, Ira, Gordon, Sharon, Kaplowitz, Gary
School: University of Maryland, Baltimore
Department: Biomedical Sciences-Dental School
School Location: United States -- Maryland
Source: MAI 53/01M(E), Masters Abstracts International
Subjects: Dentistry, Pharmacy sciences
Keywords: Anesthesia, Clinical trial, Efficacy, Intranasal, Pain, Tetracaine
Publication Number: 1556924
ISBN: 978-1-303-93391-2
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