Safety and Efficacy Study of NV-101 in Dental Patients
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|ClinicalTrials.gov Identifier: NCT00154167|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 14, 2005
The purpose of this study was:
- to determine if NV-101 accelerates recovery from numbness compared to placebo
- to evaluate safety of NV-101
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Anesthesia (Numbness)||Drug: NV-101 (phentolamine mesylate solution)||Phase 2|
This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. The investigators were licensed dentists in private practice. Each patient received one or more conventional injections of either articaine with epinephrine, lidocaine with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed within 4mm of each other constituted the same site. The injection(s) of study drug were made at or near the completion of the dental procedure and were required to be not earlier than 20 minutes after, and not later than 70 minutes after, the most recent injection of local anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local anesthetic had been injected (i.e. no more than 2 sites).
Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.
Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients|
|Study Start Date :||February 2003|
|Study Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154167
|United States, Washington|
|Tacoma, Washington, United States, 98403|
|Principal Investigator:||Royce Morrison, MD||Northwest Kinetics|