OrthoPulse Light Therapy for Teeth Alignment

Overseen By Mark N. Coreil, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biolux Technology GmbH

Disqualifiers: Anterior cross bite, spaces, extractions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new light therapy called OrthoPulse, which may accelerate teeth straightening with braces. The trial aims to assess the safety and effectiveness of this therapy in moving teeth more quickly. Participants will be divided into two groups: one using OrthoPulse and the other not using it. The trial seeks individuals who need braces, have all their adult teeth, and experience crowding in the front lower jaw. As an unphased trial, participation offers the opportunity to contribute to innovative research that could improve orthodontic care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that OrthoPulse light therapy is safe for teeth alignment?

Research has shown that OrthoPulse is safe for use with braces or clear aligners. This device uses light therapy to accelerate tooth movement, potentially shortening orthodontic treatment time. OrthoPulse is intended for daily use, requiring only 10 minutes a day to achieve results.

While specific safety data from clinical trials is not available, the device has been approved for accelerating tooth movement, indicating it meets certain safety standards. Other studies have demonstrated that patients can use OrthoPulse safely by following the instructions carefully. Consulting a healthcare provider is advisable for any concerns before starting new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about OrthoPulse light therapy for teeth alignment because it offers a unique, non-invasive approach to orthodontic treatment. Unlike traditional braces or aligners that rely on mechanical force to move teeth, OrthoPulse uses low-intensity light to stimulate bone remodeling, potentially speeding up the alignment process. This method could make orthodontic treatment more comfortable and quicker, appealing to both patients and orthodontists looking for efficient alternatives.

What evidence suggests that OrthoPulse is effective for accelerating tooth alignment?

Research has shown that OrthoPulse, which participants in this trial may receive, can accelerate the process of straightening teeth through light therapy. One study found that individuals using OrthoPulse required fewer finishing aligners, making their treatment more predictable. Another review found that light therapy can reduce the time needed for teeth to move during treatment. This suggests that OrthoPulse could expedite orthodontic procedures. The device is designed to work with braces to move teeth more quickly, thus shortening the overall treatment time for patients. ^{3 4 5 6 7}

Who Is on the Research Team?

Todd Dickerson

Principal Investigator

Private Practice 1200 W Warner Rd, Chandler, AZ 85224

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Presence of a written declaration

I have all my adult teeth.

My lower front teeth are crowded by 4-10mm.

Exclusion Criteria

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

Prior participation in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances

6 weeks

Regular visits for orthodontic adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OrthoPulse

Trial Overview

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.

How Is the Trial Designed?

Group I: OrthoPulse Experimental Treatment 1 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: Control Active Control 1 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.

OrthoPulse is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as OrthoPulse for:

• Acceleration of tooth movement during orthodontic treatment with fixed appliances or aligners

Approved in United States as OrthoPulse for:

• Acceleration of tooth movement during orthodontic treatment with fixed appliances or aligners

Approved in Canada as OrthoPulse for:

• Acceleration of tooth movement during orthodontic treatment with fixed appliances or aligners

Who Is Running the Clinical Trial?

Biolux Technology GmbH

Lead Sponsor

Trials

1

Recruited

40+

medXteam GmbH

Collaborator

Trials

2

Recruited

2,200+

Published Research Related to This Trial

A retrospective analysis of 173 medical device reports related to the Invisalign system revealed that 97.7% were adverse events, with 26% classified as serious or life-threatening, highlighting potential safety concerns associated with its use.

The most common serious adverse events included difficulty breathing, anaphylaxis, and throat swelling, indicating that healthcare providers should be vigilant and prepared to manage these reactions in patients using Invisalign.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database. Allareddy, V., Nalliah, R., Lee, MK., et al.[2017]

The hybrid approach of using clear aligners alongside fixed lingual appliances allows for more efficient treatment of malocclusions, reducing the number of aligners needed and minimizing the need for further refinements.

In this case, the combination treatment resulted in successful outcomes in just 10 weeks for the second phase, completing the entire Class III treatment in 13 months, demonstrating both effectiveness and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clear aligner hybrid approach: A case report. Lombardo, L., Palone, M., Carlucci, A., et al.[2021]

In a pilot study involving 36 subjects, low-level laser therapy (LLLT) significantly reduced the orthodontic treatment time, with the test group taking an average of 211.8 days compared to 284.1 days for the control group.

The test group also required fewer control visits (7 visits) compared to the control group (9.5 visits), indicating that LLLT may enhance the efficiency of orthodontic dental alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Low-Level Laser Therapy Enhance the Efficiency of Orthodontic Dental Alignment? Results from a Randomized Pilot Study. Caccianiga, G., Paiusco, A., Perillo, L., et al.[2018]

A study of 42 adult patients treated with Invisalign showed that ClinCheck software often overestimates the reduction of deep overbites, with only 39.2% of the predicted reduction actually achieved post-treatment.

The results indicate that patients with deeper initial overbites face greater challenges in achieving the desired outcomes, suggesting that additional strategies may be necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictability of overbite control with the Invisalign appliance. Blundell, HL., Weir, T., Kerr, B., et al.[2021]

In a study comparing 58 patients, traditional fixed appliances showed better outcomes in six smile-related variables compared to Invisalign clear aligners, indicating that fixed appliances may be more effective for certain smile improvements.

Invisalign did perform better in adjusting maxillary incisor position and inclination, but overall, traditional braces had a greater impact on the overall smile aesthetics for patients with Class I nonextraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smile outcome comparison of Invisalign and traditional fixed-appliance treatment: A case-control study. Christou, T., Abarca, R., Christou, V., et al.[2020]

Over a 5-year period, 175 adverse events and reactions (AERs) related to sequential aligners were reported in the FDA's MAUDE database, with a significant portion (73.71%) being mandatory reports from manufacturers.

Common AERs included allergic reactions (18.29%), with serious cases such as anaphylaxis (11.43%) and angioedema (2.29%), as well as other issues like gastrointestinal problems and neuromuscular symptoms, highlighting the need for awareness of potential risks associated with sequential aligner use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. Thavarajah, R., Thennukonda, RA.[2017]

In a study of 40 patients undergoing non-extraction orthodontic treatment, low-level light therapy using LEDs significantly reduced the time needed for tooth movement by 22%, with the test group taking an average of 68.3 days compared to 87.8 days for the control group.

The therapy involved daily 20-minute sessions of infrared light at a wavelength of 850 nm, suggesting that photobiomodulation could be an effective method to accelerate orthodontic treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decrowding of lower anterior segment with and without photobiomodulation: a single center, randomized clinical trial. Nahas, AZ., Samara, SA., Rastegar-Lari, TA.[2018]

In a study of 40 patients using the OrthoPulse® device alongside Invisalign® clear aligners, it was found that the device significantly reduced the need for additional finishing aligners, enhancing treatment predictability.

Patients using OrthoPulse® required only 66.5% of the initially planned aligners for finishing, compared to 103.4% in a control group, indicating that OrthoPulse® can improve the efficiency of orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictability of Invisalign® Clear Aligners Using OrthoPulse®: A Retrospective Study. Levrini, L., Carganico, A., Deppieri, A., et al.[2022]

A review of the FDA's MAUDE database revealed 104 adverse events associated with direct-to-consumer (DTC) sequential aligners, highlighting significant oral health issues such as bite problems (41.3%), orofacial pain (29.8%), and periodontal complications (26.6%).

The majority of patients (69.2%) sought follow-up care from dentists not affiliated with the DTC aligners, indicating that the lack of professional supervision during treatment can lead to serious and potentially irreversible dental problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database. Belgal, P., Mhay, S., Patel, V., et al.[2023]

The use of the AcceleDent device during aligner treatment significantly accelerated orthodontic tooth movement, allowing patients to complete their treatment in an average of 9 days per aligner compared to 15 days in the control group, demonstrating a substantial time-saving benefit.

Patients using AcceleDent reported lower pain perception during the first week of treatment, indicating that this device not only speeds up the process but may also enhance patient comfort during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Low-frequency Vibration on Aligner Treatment Duration: A Clinical Trial. Bilello, G., Fazio, M., Currò, G., et al.[2022]

In a study of 81 adult patients treated with the Invisalign system, significant improvements in oral health-related quality of life were reported, particularly in appearance and eating, with over 70% of participants expressing satisfaction in these areas.

The doctor-patient relationship was found to be a key factor influencing overall patient satisfaction, with positive interactions correlating strongly with improvements in dentofacial appearance and treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction and quality of life changes after Invisalign treatment. Pacheco-Pereira, C., Brandelli, J., Flores-Mir, C.[2018]

Tooth displacement during orthodontic treatment can be influenced by adjusting the intensity of applied forces or using medicated molecules, highlighting the importance of force modulation in effective treatment.

However, practitioners must be cautious of potential harmful side effects, such as inflammatory root resorption or ankylosis, which require careful management to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tooth movement - clinical implications. Sastre, J., Le Gall, M.[2016]

Aligners can effectively treat anterior spaces caused by periodontal diseases without causing damage to periodontal tissues, as observed in a study of seven patients.

No significant changes were noted in periodontal health indicators, such as bleeding on probing and probing depth, before and after treatment, indicating the safety of using aligners in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patients with anterior spaces caused by periodontal disease treated with aligner technique]. Bai, YX., Yang, B., Dai, Q., et al.[2009]

In a study involving 80 rats, LED phototherapy did not enhance the amount of orthodontic tooth movement compared to a control group, indicating that it may not be an effective treatment for accelerating tooth movement during orthodontics.

Both the LED and control groups exhibited similar levels of hyalinization and root resorption, suggesting that LED phototherapy does not significantly alter these common effects associated with orthodontic tooth movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infrared Light-Emitting Diode (LED) Effects on Orthodontic Tooth Movement. Friedrichsdorf, SP., Chavez, VEA., Bradaschia-Correa, V., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9777085/

Predictability of Invisalign® Clear Aligners Using OrthoPulse

The statistical analysis showed that patients who used OrthoPulse® needed fewer finishing aligners and a greater predictability of the treatment ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03683017

OrthoPulse 2.0 and 2.1 Feasibility Evaluation

OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse ...

3.

withpower.com

withpower.com/trial/phase-focus-is-the-safety-and-performance-of-orthopulse-9-2022-54b2c

OrthoPulse Light Therapy for Teeth Alignment

This trial is testing a light therapy device called OrthoPulse to see if it can help people with braces move their teeth faster.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405844023004279

Efficiency of photobiomodulation on accelerating the tooth ...

This systematic review offered evidence that photobiomodulation can accelerate tooth movement in alignment procedures and reduce treatment time.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02267837

OrthoPulse™ and Its Effect on the Rate of Orthodontic ...

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior ...

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K230905.pdf

K230905 - accessdata.fda.gov

The OrthoPulse® device is intended to accelerate orthodontic movement of teeth which may reduce the overall treatment time for the patient.

7.

orthopulse.com

orthopulse.com/

OrthoPulse® | Light up your Smile. Faster.

Designed for use with braces or clear aligners. · Safe and simple. Results with just 10 minutes a day. · Helps your teeth align more precisely with your aligners.