Using OrthoPulse to speed up tooth movement in orthodontics
Official title: A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
Run by Biolux Technology GmbH · NCT05650359 · Data updated 2026-11-12
This study is testing if a new light treatment called OrthoPulse can help speed up tooth movement for people getting braces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Biolux Technology GmbH Industry-sponsored |
| Locations | 1 site (Chandler, Arizona) |
| Status | Recruiting |
| Started | October 13, 2022 |
| Main results expected | May 15, 2028 |
| Study ends | May 15, 2028 |
| Registry record updated | August 7, 2024 |
| Trial ID | NCT05650359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who require orthodontic treatment with fixed appliances and have specific malocclusions and crowding.
✕Probably not a fit
Patients with certain dental conditions such as anterior crossbite, missing teeth, or acute oral infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation evaluates the safety and performance of OrthoPulse photobiomodulation technology to accelerate tooth movement during orthodontic treatment with fixed appliances. The study compares two groups: one receiving the OrthoPulse intervention and a control group receiving no intervention. The hypothesis is that subjects in the intervention group will experience a statistically significant increase in the rate of tooth movement, estimated to be 1.8 times faster than those in the control group. This post-market clinical follow-up aims to substantiate clinical data for the application of OrthoPulse in orthodontics.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the duration of orthodontic treatment for patients.
How similar studies have gone: While the use of photobiomodulation in orthodontics is a relatively novel approach, preliminary studies have shown promising results in accelerating tooth movement.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
Private Practice
Chandler, Arizona, United States Recruiting
Study contacts
- Principal investigator: Todd Dickerson — Private Practice 1200 W Warner Rd, Chandler, AZ 85224
- Study coordinator: Daniela Penn
- Email: daniela.penn@medxteam.de
- Phone: 063219164033
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.