Malocclusion
Conditions
Brief summary
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
Detailed description
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
Interventions
DEVICEInvisalign
Sponsors
Align Technology, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Subject must have fully erupted dentition except for 2nd and 3rd molars * For Teen treatment group, subjects ages \<17 years of age * For Adult treatment group, subjects ≥17 years of age
Exclusion criteria
* Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study * Subject with active caries * Subject with periodontal disease * Subject with TMD symptoms * Subject has known allergy to latex or plastic * Subjects who are pregnant or will become pregnant during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Planned to Final Tooth Position | Through study completion, an average of 2 years | Test vs Historical Control Group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment time | Through study completion, an average of 2 years | Length of treatment |
| Subject Quality of Life | Through study completion, an average of 2 years | Assessment of QoL |
Countries
Canada, United States
Outcome results
None listed