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Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures

2014-08-27 03:45:24 | BioPortfolio

Summary

This Phase 3 clinical 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 vasodilatation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.

Study Design

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

Conditions

Anesthesia, Dental

Intervention

Phentolamine Mesylate (NV-101)

Location

Tufts University School of Dental Medicine
Boston
Massachusetts
United States
02111

Status

Completed

Source

Novalar Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:24-0400

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Medical and Biotech [MESH] Definitions

A technique using a pneumatic, high-pressure stream of aluminum oxide to remove DENTAL ENAMEL; DENTIN; and restorative materials from teeth. In contrast to using DENTAL HIGH-SPEED EQUIPMENT, this method usually requires no dental anesthesia (ANESTHESIA, DENTAL) and reduces risks of tooth chipping and microfracturing. It is used primarily for routine DENTAL CAVITY PREPARATION.

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Abnormally slow pace of regaining CONSCIOUSNESS after general anesthesia (ANESTHESIA, GENERAL) usually given during surgical procedures. This condition is characterized by persistent somnolence.

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An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

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