RecruitingNot Applicable

Study of the Use of Orthopulse Photobiomodulation

United States42 participantsStarted 2022-10-13

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 42 days after start of treatment

Trial details

NCT IDNCT05650359

SponsorBiolux Technology GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-15

Contact for this trial

Daniela Penn

063219164033 daniela.penn@medxteam.de

View on ClinicalTrials.gov More Orthodontics trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.