Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

Completed · Phase 4

Conditions studied: Periodontal Disease

In brief

To establish Oraqix is safe when used on adolescent volunteers.

Key facts

Study ID

NCT01591616

Run by

Dentsply International

People needed

16

Starts

2010-04-01

Expected to finish

2012-04-01

Last updated by the study team

2020-08-07

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonweath School of Dentistry — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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