Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2016-12-01
2020-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Multiforce
Variable modulus version of a current orthodontic archwire
Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
CuNiTi A
.016" current orthodontic archwire
Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
CuNiTi B
0.014" and 0.018" current orthodontic archwire sequence
Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Interventions
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Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Ormco Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kelton T Stewart, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana Unversity
Locations
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IUSD Orthodontic Clinic
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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1608063565
Identifier Type: -
Identifier Source: org_study_id
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