Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients
NCT ID: NCT01474382
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2012-02-29
2014-08-31
Brief Summary
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Detailed Description
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The primary endpoint is safety and tolerability of OraVerse as measured by adverse events, vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain. Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation procedure.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OraVerse
OraVerse in doses of either 1/4, 1/2 or 1 cartridge (1.8mL)
OraVerse
1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight
Sham injection
Dentist simulates injection with dental syringe
Sham injection
No drug administered, simulation of injection used in same manner as drug
Interventions
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OraVerse
1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight
Sham injection
No drug administered, simulation of injection used in same manner as drug
Eligibility Criteria
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Inclusion Criteria
* Sufficiently healthy as determined by the Investigator to receive routine dental care
* Requires a restorative procedure (restoration/filling) in a single quadrant of the mouth
* Requires local anesthesia with lidocaine 2% with 1:100,000 epinephrine administered by submucosal injection
* For subjects undergoing mandibular procedures, require an inferior alveolar nerve block for the restorative procedure
* Dental procedure(s) completed within 60 minutes of injection of local anesthetic
* For subjects 4 and 5 years of age, can be trained in standardized lip/tongue palpation procedure and pFAB
* Subjects who are trainable in pFAB and standardized lip/tongue palpation procedure have either:
* normal pFAB at baseline prior to administration of local anesthetic and
* at least one abnormal function (smiling, speaking, drinking or drooling) at the completion of the dental procedure OR
* normal lip sensation at baseline prior to administration of local anesthetic and
* numbness of the relevant lip quadrant at completion of the dental procedure
* Subjects give written or verbal assent, as capable and appropriate, and parent(s) or legal guardian(s) give written informed consent
Exclusion Criteria
* Weight less than 15 kg if 4 or 5 years of age
* History or presence of any condition that contraindicates routine dental care or use of local anesthetic
* Requires more than ¼ cartridge of local anesthetic if weight is ≥ 10 kg and \< 15 kg, more than ½ cartridge of local anesthetic if weight is ≥ 15 kg and \< 30 kg, and more than 1 cartridge of local anesthetic if weight is ≥ 30 kg, excluding supplemental injections
* Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, nitrous oxide or topical benzocaine
* Has used any 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 use of commercial OraVerse™ within 30 days of study drug administration
* Use of opioid or opioid-like analgesics within 24 hours prior to administration of local anesthetic
* Requires the use of local anesthetic other than lidocaine 2% with 1:100,000 epinephrine to perform the scheduled dental procedure
* Requires the use of general anesthesia or sedatives except for nitrous oxide to perform the scheduled dental procedure
* 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
2 Years
5 Years
ALL
Yes
Sponsors
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Novocol Pharmaceutical of Canada, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Moore, DMD,PhD,MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh School of Dental Medicine
Elliot Hersh, DMD,MS,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Joel Berg, DDS,MS
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Judith Chin, DDS,MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Brent Lin, DMD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Paul Casamassimo, MS,DDS
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Adam Marberger, DDS
Role: PRINCIPAL_INVESTIGATOR
Jean Brown Research
Locations
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University of California, San Francisco
San Francisco, California, United States
Indiana University School of Dentistry
Indianapolis, Indiana, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania School of Dental
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States
Jean Brown Research
Salt Lake City, Utah, United States
Center for Pediatric Dentistry
Seattle, Washington, United States
Countries
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References
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Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8):1080-93. doi: 10.14219/jada.archive.2008.0311.
Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-3006(2008)55[40:POLWEF]2.0.CO;2.
Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. 2008 Aug;139(8):1095-104. doi: 10.14219/jada.archive.2008.0312.
Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. doi: 10.1177/154405910808700717.
Other Identifiers
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PHE-11-001
Identifier Type: -
Identifier Source: org_study_id