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| Name | Class |
|---|---|
| Indiana University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiforce | Experimental | Variable modulus version of a current orthodontic archwire |
|
| CuNiTi A | Active Comparator | .016" current orthodontic archwire |
|
| CuNiTi B | Active Comparator | 0.014" and 0.018" current orthodontic archwire sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthodontic archwire | Device | Archwire used to align teeth in an orthodontic fixed appliance |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Medical/Dental History (Hx):
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| Name | Affiliation | Role |
|---|---|---|
| Kelton T Stewart, DDS, MS | Indiana Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUSD Orthodontic Clinic | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D012391 | Root Resorption |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D014091 | Tooth Resorption |
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Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
| Initial six months of treatment |