OrthoPulse: 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: No intervention
Study summary
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
The primary endpoint of this PMCF study is the rate of tooth alignment. — 42 days after start of treatment 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.
Trial sites (1)
Facility
City
Region
Status
Private Practice
Chandler
Arizona
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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