K07
Conditions
Interventions
Group 1: Each patient is his own control: The patient is initially randomized and blinded to either group A (investigational device) or group B (control). After the first treatment phase and a wash-ou
Sponsors
Biolux Technology GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Indication for a treatment with aligners • Presence of a signed informed consent • Lower anterior teeth crowding of approx 3-8mm (estimated traditionally)
Exclusion criteria
Exclusion criteria: • Pregnancy • Simultaneous participation in another clinical investigation or study • Prior participation in this study • Persons who have been placed in an institution as a result of an administrative or judicial order • Persons who are dependent on the sponsor, investigator or the investigation site • IPR (inter proximal reduction required in first 2 months of Invisalign treatment) • Patients undergoing class II and III corrections during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this PMCF study is the increased speed of tooth movement in case of the application of OrthoPulse versus no application of OrthoPulse. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Tooth pain (reduction in pain) • Rate of tooth movement • Patient satisfaction • Safety (AEs, incidents, side effects, complications) | — |
Countries
Germany
Contacts
Public ContactDaniela Penn
medXteam GmbH
Outcome results
None listed