Study of the Use of Orthopulse Photobiomodulation

Launched by BIOLUX TECHNOLOGY GMBH · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is examining a new treatment called OrthoPulse photobiomodulation, which uses light therapy to help speed up the movement of teeth during orthodontic treatment with braces. The goal is to see if this method is safe and effective in helping people achieve their desired smiles more quickly.

To participate in this study, you need to be at least 18 years old and require orthodontic treatment with fixed braces. You should have permanent teeth and a specific type of bite problem called Class I-III malocclusion, along with some crowding in your front teeth. However, this trial is not for everyone; for example, if you are pregnant, have certain dental issues, or are currently in another study, you won't be eligible. If you do join the study, you can expect regular check-ups to monitor your progress and see how well the OrthoPulse treatment works alongside your braces.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: at least 18 years
• • Indication for an orthodontic treatment with fixed appliances
• • Presence of a written declaration
• • Permanent dentition
• • Class I-III malocclusion
• • Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)
• Exclusion Criteria:
• • 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
• • Anterior cross bite
• • Spaces between anterior teeth
• • Extractions or missing permanent teeth (except for third molars)
• • No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase
• • Acute oral infection or periodontal disease
• • Active caries
• • Pregnant patients or patients planning to become pregnant

Trial Officials