Evaluation of the acceleration of tooth movement when OrthoPulse is applied in case of aligners: a PMCF study

Not Applicable

Recruiting

• Conditions: K07; Dentofacial anomalies [including malocclusion]

• Registration Number: DRKS00030906
• Lead Sponsor: Biolux Technology GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

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

•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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
•Tooth pain (reduction in pain) <br>•Rate of tooth movement <br>•Patient satisfaction<br>•Safety (AEs, incidents, side effects, complications)