Anesthesia, DentalPhase 3NCT00309335
Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures
A Phase 3 study testing Phentolamine Mesylate (NV-101) in people with Anesthesia, Dental, run by Novalar Pharmaceuticals, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anesthesia, Dental
- What is being tested?
- Phentolamine Mesylate (NV-101)
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Maxillary Procedures
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.
- Conditions
- Anesthesia, Dental
- Being tested
- Phentolamine Mesylate (NV-101)
- Keywords
- Soft Tissue Anesthesia (Numbness)
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Mesylate (NV-101)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if NV-101 accelerates time to normal sensation of the upper lip compared to control, as measured by standardized palpation procedure
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startFeb 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Novalar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Athena Papas, DMD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309335
- Sponsor's protocol ID
- NOVA 04-200
- Status last verified
- Nov 2006
- First submitted
- 30 Mar 2006
- Last updated
- 17 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Maxillary Procedures
- ClinicalTrials.gov ID
- NCT00309335
- Acronym / sponsor ID
- NOVA 04-200
- Conditions
- Anesthesia, Dental
- Keywords
- Soft Tissue Anesthesia (Numbness)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Novalar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Jul 2006
- First posted
- 31 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Dental procedure is completed within 60 minutes of the first administration of local anesthetic
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentolamine Mesylate (NV-101) | Drug | – |
Primary outcome
to determine if NV-101 accelerates time to normal sensation of the upper lip compared to control, as measured by standardized palpation procedure
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Papas, DMD principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phentolamine Mesylate (NV-101) in people with Anesthesia, Dental, run by Novalar Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine if NV-101 accelerates time to normal sensation of the upper lip compared to control, as measured by standardized palpation procedure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2006.