Malocclusion
Conditions
Brief summary
The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.
Detailed description
Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.
Interventions
DEVICEMovement Enhancement Technique
Conventional Orthodontic treatment
DEVICEClear Aligner
Orthodontic treatment with Clear Aligner
Sponsors
Align Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
* Require Orthodontic Treatment * Have a permanent dentition * No craniofacial anomaly present * No past and present signs and symptoms of periodontal disease * No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement * No previous orthodontic or orthopaedic relapse * No history of trauma, bruxism or parafunction * 16- 46 years old, inclusive * No skeletal jaw discrepancy * Angle Class I or Class II molar and canine relationship * Crowding of at least 4mm per arch * No osteoporosis drugs
Exclusion criteria
* Subjects who do not fulfill all inclusion criteria requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Movement Change | Baseline and end of treatment, an average of 78 weeks | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Treatment Change | Baseline and end of treatment, an average of 78 weeks | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Movement Enhancement Technique Movement Enhancement Technique Clear Aligner
Movement Enhancement Technique: Conventional Orthodontic treatment
Clear Aligner: Orthodontic treatment with Clear Aligner | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Movement Enhancement Technique | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 90 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 90 participants | — |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Tooth Movement Change
Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.
Time frame: Baseline and end of treatment, an average of 78 weeks
Population: all completed subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Movement Enhancement Technique | Tooth Movement Change | 0.363 millimeters |
Secondary
Length of Treatment Change
Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner.
Time frame: Baseline and end of treatment, an average of 78 weeks
Population: all completed subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Movement Enhancement Technique | Length of Treatment Change | 342 days |