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Study of OrthoPulse for Faster Orthodontic Treatment

This study is looking at how well the OrthoPulse device works to speed up tooth movement during orthodontic treatment with braces. The OrthoPulse device uses light to potentially accelerate how quickly your teeth move. You might be able to join if you are at least 18 years old, need orthodontic treatment with fixed braces, and have 4-10mm of crowding in your lower front teeth. The main goal is to see if people using OrthoPulse have faster tooth alignment compared to those who don't. The study aims to show that OrthoPulse could make teeth move about 1.8 times faster. The current recruitment status is unclear.

Study design
This study plans to enroll 42 participants and compares those using OrthoPulse to those receiving no intervention. It is an interventional study, but the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured 42 days after the start of treatment, indicating a follow-up period of at least this length.

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NCT05650359

Study of the Use of Orthopulse Photobiomodulation

Recruiting
NAAges 18+InterventionalTreatment
Biolux Technology GmbH
~42 participants
Updated 2024-08-07 on ClinicalTrials.gov
What's tested:OrthoPulseNo intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint of this PMCF study is the rate of tooth alignment.
Measured over 42 days after start of treatment

Conditions

Orthodontics

Explore related trials

Malocclusion

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Todd Dickerson · PRINCIPAL_INVESTIGATOR · Private Practice 1200 W Warner Rd, Chandler, AZ 85224

Who to contact

Daniela Penn
[email protected]
063219164033
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.