Overview

Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
To establish Oraqix is safe when used on adolescent volunteers.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dentsply International
Treatments:
EMLA
Lidocaine
Prilocaine
Criteria
Inclusion Criteria:

- 6 and 17 and eleven twelfths

- requires tooth extraction

- healthy having not taken any prescription or over the counter medications within 60
days of first visit

- must be a minimum of 15 kg

Exclusion Criteria:

- anesthesia required for treatment other than study material

- given blood within 90 days of first visit

- pregnant

- allergic to local anesthetic

- documented history of glucose-6-phosphate dehydrogenase deficiency

- history of congenital idiopathic methemoglobinemia

- does not have a loose tooth easily extracted or who, in the opinion of the
Investigator, is not suitable for tooth extraction using only topical anesthetic