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.
|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|
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