Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
Summary
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled
study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11
years of age. NV-101 or sham injection is administered at the completion of a dental
procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental
procedure(s) shall be performed in a single quadrant of the mouth and include cavity
preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing),
or crowns.