NCT05650359 · Biolux Technology GmbH
Study of the Use of Orthopulse Photobiomodulation
What this study is about
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
View original scientific description
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
Interventions
DEVICE
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.
OTHER
No intervention
No intervention
Primary outcome measures
The primary endpoint of this PMCF study is the rate of tooth alignment.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chandler, Arizona
Collaborators
medXteam GmbH
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2024 · Source of record for eligibility and locations