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Recruiting NCT05650359

A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation

Conditions: Focus is the Safety and Performance of OrthoPulse

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 42
Sponsor: Biolux Technology GmbH

Location: United States

Summary

This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

Eligibility Criteria

Inclusion Criteria:Age: at least 18 yearsIndication for an orthodontic treatment with fixed appliancesPresence of a written declarationPermanent dentitionClass I-III malocclusionBetween 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 studyPrior participation in this studyPersons who have been placed in an institution as a result of an administrative or judicial orderPersons who are dependent on the sponsor, Investigator or the investigation siteAnterior cross biteSpaces between anterior teethExtractions or missing permanent teeth (except for third molars)No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phaseAcute oral infection or periodontal diseaseActive cariesPregnant patients or patients planning to become pregnant

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05650359). StuddyBuddy aggregates publicly available trial information.