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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00309335
• Date of registration: 30/03/2006
• Primary sponsor: Novalar Pharmaceuticals, Inc.
• Public title: Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures
• Scientific title: A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Maxillary Procedures
• Date of first enrolment: February 2006
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00309335
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Athena Papas, DMD
• Affiliation: Tufts University School of Dental Medicine

Key inclusion & exclusion criteria

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 maxilla 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 upper
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 upper lip sensations at baseline prior to administration of local anesthetic

- Upper 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



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anesthesia, Dental

Intervention(s)

Drug: Phentolamine Mesylate (NV-101)

Primary Outcome(s)

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

Secondary Outcome(s)

to characterize the pharmacodynamic profile of NV-101, as measured by onset and offset of treatment effect

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 determine if NV-101 accelerates the time to STAR-7 score of zero, as measured by soft tissue anesthesia questionnaire

to evaluate the safety and tolerability of NV-101

Secondary ID(s)

NOVA 04-200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors