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