Orthodontic Archwire Comparison Trial

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.

Inclusion Criteria:

- Adult >14yrs of age

- Amenable to treatment with metal brackets

- Crowding of 3-8mm in one or both arches (non-extraction treatment)

- Overbite >3mm

- Read and speak English without a translator

- Individuals in good general health at the discretion of the investigator(s)

Exclusion Criteria:

- Medical/Dental History (Hx):

- Documented metabolic disorder(s)

- Nickel allergy

- Bisphosphonate treatment

- Amelogenesis, dentinogenesis or osteogenesis imperfect

- Active caries or periodontal disease

- Root resorption (moderate to severe)

- Patients who are pregnant or breast feeding or plan to be pregnant during the
study