Clinical Trial: Orthodontic Archwire Comparison Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief 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 Summary:

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.


Sponsor: Ormco Corporation

Current Primary Outcome: Alignment of dental arches [ Time Frame: Initial six months of treatment ]

Tooth alignment rate in response to force from archwire measured in mm on dental models


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Leveling of dental arches [ Time Frame: Initial six months of treatment ]
    Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
  • Expression of external apical root resorption (EARR) [ Time Frame: Initial six months of treatment ]
    Amount of root resorption in response to force from archwire calculated in 3D from the CBCT


Original Secondary Outcome: Same as current

Information By: Ormco Corporation

Dates:
Date Received: November 29, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: December 22, 2016
Last Verified: December 2016