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

November 16, 2006 updated by: Novalar Pharmaceuticals, Inc.

A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Mandibular Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female greater than or equal to 12 years
  • Sufficiently healthy, as determined by the Investigator, to receive routine dental care
  • Requires a restorative procedure in the mandible such as cavity preparation, restoration/filling, or crown or a periodontal maintenance procedure, such as teeth cleaning (non-surgical scaling and/or root planing) on the same side of the lower mouth

  • Requires one or two cartridges of local anesthesia administered by one of the following intraoral injection techniques:

    • inferior alveolar nerve block;
    • Gow-Gates nerve block;
    • Vazirani-Akinosi block;
    • mental-incisive block; or
    • supraperiosteal injection.
  • Dental procedure is completed within 60 minutes of the first administration of local anesthetic
  • Normal lower lip and tongue sensations at baseline prior to administration of local anesthetic
  • Lower lip on the side of the procedure is numb (no feeling) at the completion of the dental procedure
  • Soft tissue anesthesia recovery score of zero prior to anesthetic
  • Functional Assessment Battery by subject and observer rating is normal prior to anesthetic
  • Negative urine pregnancy test at screening in all females of childbearing potential past menarche (includes all females except for those whose menstrual periods have not occured for greater than or equal to 1 year after menopause, who are surgically sterilized or who had a hysterectomy)
  • Understands and gives written informed consent
  • Subjects 12 to 17 years of age give written assent and parent(s) or legal guardian(s) give written informed consent
  • Can communicate with the Investigator and study staff, and can understand and comply with the requirements of the protocol

Exclusion Criteria:

  • History or presence of any condition that contraindicates routine dental care
  • Requires more than two cartridges of local anesthetic (excluding supplemental injections) or use of nitrous oxide or sedatives to perform the scheduled dental procedure
  • Scheduled dental procedure takes greater than 60 minutes to complete
  • Unable to tolerate 1 liter of water over 5 hours
  • Concurrent conditions: any incapacitating medical condition (e.g. unstable angina, uncontrolled cardiac arrhythmias, uncontrolled hypertension, uncontrolled hyperthyroidism); significant infection or inflammatory process of the oral cavity.
  • Concomitant medications: use of an opioid or opioid-like analgesic (e.g. codeine, tramadol, pentazocine) within 24 hours prior to administration of anesthetic
  • Allergy or intolerance to lidocaine, articaine, prilocaine, mepivacaine, epinephrine, levonordefrin, sulfites, phentolamine, or topical benzocaine
  • Has used an investigational drug and/or participated in any clinical study within 30 days of study drug administration
  • Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
  • Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
to determine if NV-101 accelerates time to normal sensation of the lower lip compared to control, as measured by standardized palpation procedure

Secondary Outcome Measures

Outcome Measure
to determine if NV-101 accelerates the time to STAR-7 score of zero, as measured by soft tissue anesthesia questionnaire
to determine if NV-101 accelerates the time to normal function, as measured by a functional assessment battery
to determine if NV-101 accelerates the time to normal sensation of the tongue, as measured by standardized palpation procedure
to characterize the pharmacodynamic profile of NV-101, as measured by onset and offset of treatment effect
to evaluate the safety and tolerability of NV-101

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novalar Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Athena Papas, DMD, Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

March 30, 2006

First Submitted That Met QC Criteria

March 30, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2006

Last Update Submitted That Met QC Criteria

November 16, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOVA 04-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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