Study of the Use of Orthopulse Photobiomodulation
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
| Condition(s) | Orthodontics |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances. |
| Who can participate | 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 require |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Biolux Technology GmbH |
| Locations | Chandler, Arizona, United States |
| Start date | 2022-10-13 |
| NCT ID | NCT05650359 |
| Official listing | https://clinicaltrials.gov/study/NCT05650359 |