NCT02983084

Orthodontic Archwire Comparison Trial

SmartWire Multiforce Archwire Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Ormco Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.

Detailed description

This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used. Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment. Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects. Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Orthodontic archwire	Archwire used to align teeth in an orthodontic fixed appliance

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-31
• Completion: 2020-03-31
• First posted: 2016-12-06
• Last updated: 2019-01-15

Locations

1 site across 1 country: United States