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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

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    Author
    Sabti, Mohammad Y.
    Advisor
    Gordon, Sharon M.
    Date
    2014
    Type
    dissertation
    
    Metadata
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    Abstract
    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.
    Description
    University of Maryland, Baltimore. Biomedical Sciences-Dental School. M.S. 2014
    Keyword
    efficacy
    intranasal
    Administration, Intranasal
    Anesthesia, Dental
    Clinical Trial
    Pain
    Tetracaine
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/4068
    Collections
    Theses and Dissertations All Schools
    Theses and Dissertations School of Dentistry

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