What is the mechanism of action of this treatment?

Orthodontic treatments commonly involve the use of braces or aligners to apply continuous pressure on teeth, gradually moving them into the desired position. The mechanisms of action include bone remodeling, where osteoclasts break down bone tissue on the pressure side of the tooth and osteoblasts build up bone on the tension side. Photobiomodulation, such as that studied in the OrthoPulse trial, uses low-level laser therapy to accelerate tooth movement by enhancing cellular activity and reducing inflammation. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment, managing expectations, and improving overall treatment outcomes.

What side effects are associated with this type of intervention?

Common orthodontic treatments, including braces, aligners, and photobiomodulation like OrthoPulse, can have several side effects. Braces and aligners may cause discomfort, pain, mouth sores, and irritation of the gums and cheeks. They can also lead to tooth decay and gum disease if proper oral hygiene is not maintained. Photobiomodulation treatments like OrthoPulse are generally well-tolerated, but potential side effects may include temporary discomfort or sensitivity in the treated areas. It is important to discuss these potential side effects with an orthodontist to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved various devices and treatments for orthodontics, including traditional braces, clear aligners like Invisalign, and other orthodontic appliances. Specifically, for treatments similar to OrthoPulse, which uses photobiomodulation, the FDA has approved devices such as AcceleDent, which also aims to accelerate tooth movement through micro-pulse technology. These devices are designed to complement traditional orthodontic treatments by reducing treatment time and improving patient comfort.

What other types of research exist?

Promising alternatives to OrthoPulse for orthodontic patients in 2024 include: 1) Customized mandibular advancement devices, which are tailored to individual patient anatomy and can improve treatment efficacy and comfort. 2) Advanced clear aligner systems with integrated smart technology for real-time monitoring and adjustments. 3) Low-level laser therapy (LLLT), which has shown potential in accelerating tooth movement and reducing treatment time. 4) 3D-printed orthodontic appliances, offering precise customization and potentially faster treatment times.

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Photobiomodulation

OrthoPulse Light Therapy for Teeth Alignment

N/A

Recruiting

Led By Todd Dickerson

Research Sponsored by Biolux Technology GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days after start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a light therapy device called OrthoPulse to see if it can help people with braces move their teeth faster. The study focuses on patients who are currently using braces. OrthoPulse works by using light to speed up the activity of cells in the mouth, which helps teeth move more quickly.

Who is the study for?

This trial is for adults with 4-10mm crowding in lower front teeth, needing braces for Class I-III malocclusion. Candidates must not be institutionalized by order, dependent on the sponsor or site, have gaps in front teeth, need other oral devices during the study phase, have untreated cavities or missing teeth (except wisdom), be in another study or this one before, have a crossbite upfront, or be pregnant/planning pregnancy.

What is being tested?

The study tests OrthoPulse photobiomodulation's safety and effectiveness to speed up tooth movement with braces. Participants will either receive OrthoPulse treatment alongside regular orthodontic care or undergo standard treatment without additional interventions.

What are the potential side effects?

While specific side effects are not detailed here, photobiomodulation generally has minimal risks which may include mild discomfort at the application site. The procedure is non-invasive and considered safe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days after start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days after start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days after start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OrthoPulseExperimental Treatment1 Intervention

The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment.

Group II: ControlActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Orthodontic treatments commonly involve the use of braces or aligners to apply continuous pressure on teeth, gradually moving them into the desired position. The mechanisms of action include bone remodeling, where osteoclasts break down bone tissue on the pressure side of the tooth and osteoblasts build up bone on the tension side. Photobiomodulation, such as that studied in the OrthoPulse trial, uses low-level laser therapy to accelerate tooth movement by enhancing cellular activity and reducing inflammation. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment, managing expectations, and improving overall treatment outcomes.