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NCT05650359NARecruitingAccepts Healthy Volunteers

Study of the Use of Orthopulse Photobiomodulation

Biolux Technology GmbH

Start Date

10/13/2022

Completion Date

5/15/2028

Summary

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

Detailed Description

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

OrthoPulse

OTHER

No intervention

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Conditions

Orthodontics

Locations

Private Practice

Chandler, Arizona 85224

United States