Malocclusion
Conditions
Keywords
Orthodontic wires, Root resorption
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 description
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.
Interventions
DEVICEOrthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Sponsors
Indiana University
Ormco Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alignment of dental arches | Initial six months of treatment | Tooth alignment rate in response to force from archwire measured in mm on dental models |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leveling of dental arches | 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) | Initial six months of treatment | Amount of root resorption in response to force from archwire calculated in 3D from the CBCT |
Countries
United States
Outcome results
None listed