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Clinical Trial Summary

This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00309361
Study type Interventional
Source Novalar Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date February 2006
Completion date July 2006

See also
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Completed NCT04317508 - Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection Phase 1/Phase 2
Completed NCT00363207 - Behavior of Children Related to Numbness After Dental Local Anesthesia N/A
Completed NCT00309322 - Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures Phase 2
Completed NCT00309335 - Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures Phase 3
Completed NCT05839093 - Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis N/A
Completed NCT05423392 - Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children N/A