Orthodontic Archwire Comparison Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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SmartWire Multiforce Archwire Clinical Trial

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Orthodontic archwire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiforce<br>Variable modulus version of a current orthodontic archwire | Device: Orthodontic archwire<br>* Archwire used to align teeth in an orthodontic fixed appliance<br>* Other names: Copper Nickel Titanium;|
| Active Comparator: CuNiTi A<br>.016 current orthodontic archwire | Device: Orthodontic archwire<br>* Archwire used to align teeth in an orthodontic fixed appliance<br>* Other names: Copper Nickel Titanium;|
| Active Comparator: CuNiTi B<br>0.014 and 0.018 current orthodontic archwire sequence | Device: Orthodontic archwire<br>* Archwire used to align teeth in an orthodontic fixed appliance<br>* Other names: Copper Nickel Titanium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alignment of dental arches | Tooth alignment rate in response to force from archwire measured in mm on dental models | Initial six months of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic wires, Root resorption