Study of the Use of Orthopulse Photobiomodulation

ConditionOrthodontics

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBiolux Technology GmbH

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: at least 18 years

Indication for an orthodontic treatment with fixed appliances

Presence of a written declaration

Permanent dentition

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

OrthoPulse
Device
The OrthoPulse device is intended to accelerate orthodontic movement of teeth and reduce the overall treatment time for the patient. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners. OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses safe, high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. OrthoPulse is an established device that uses low levels of light energy to stimulate the bone surrounding the roots of teeth and facilitate tooth movement which may reduce treatment time for braces or clear aligners.
No intervention
Other intervention
No intervention

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: OrthoPulseExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

The primary endpoint of this PMCF study is the rate of tooth alignment.

The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment.

Time frame

42 days after start of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biolux Technology GmbH

Lead sponsor

medXteam GmbH

Collaborator

Source ClinicalTrials.gov

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