Study of the Use of Orthopulse Photobiomodulation

The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).

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