N/A
N=164
Class II Correction Study Using the Invisalign System
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02376829 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Rate of Tooth Movement at the End of Class II Correction. — .44 mm/month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Invisalign System (Device)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Align Technology, Inc.
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Tooth Movement at the End of Class II Correction. |
.44 | — |
| SECONDARY Length of Treatment Time |
461 | — |
| SECONDARY Patient Quality of Life Questionnaire Throughout Treatment |
4.24; 4.28; 4.39 | — |
| SECONDARY Doctor Survey for Satisfaction With Treatment Outcomes |
4.56 | — |
Summary
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Eligibility Criteria
Inclusion Criteria
- Subject must have fully erupted dentition excluding 2nd and 3rd molars
- Age range 11-19 years old
- Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship
Exclusion Criteria
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has spaces between adjacent teeth larger than 3mm
- Subject with active caries
- Subject with periodontal disease
- Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
- Subject with TMD (Temporomandibular joint dysfunction) symptoms
- Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
- Subject has known allergy to latex and plastic
- Subjects who are pregnant or will become pregnant during treatment
Data sourced from ClinicalTrials.gov (NCT02376829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.