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MalocclusionBX13NCT03683017

OrthoPulse 2.0 and 2.1 Feasibility Evaluation

A study testing OrthoPulse 2.0, OrthoPulse 2.1 and Invisalign 3.5 Day Wear in people with Malocclusion, run by Biolux Research Holdings, Inc. at 7 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness. Read more about this study

Who is it for?
Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for
Malocclusion
What is being tested?
OrthoPulse 2.0, OrthoPulse 2.1 and Invisalign 3.5 Day Wear
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
7 sitesin 2 countries
Study dates
22 Dec 2017to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Written Informed Consent must be obtained before any assessment is performed
  • Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
  • Presence of permanent dentition
  • Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
  • Good oral hygiene
  • Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
  • Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data

Who cannot join

  • Patient is currently enrolled in another clinical study
  • Periodontally involved teeth, acute oral infection or periodontal disease
  • Use of bisphosphonates (osteoporosis drugs) during the study
  • Use of drugs that may cause photosensitivity
  • History of photosensitivity
  • History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
Show all 9Show fewer
  • Epilepsy
  • Patient plans to relocate over the treatment period
  • Smoker or use of any tobacco containing products per the discretion of the PI

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • Dickerson Orthodontics

    Chandler, Arizona, 85224

  • Chenin Orthodontics

    Henderson, Nevada, 89052

  • Dickerson Orthodontics

    Peoria, Arizona, 85382

  • Dickerson Orthodontics

    Phoenix, Arizona, 85028

  • Bella Smile

    San Francisco, California, 94118

  • Dickerson Orthodontics

    Scottsdale, Arizona, 85254

Other trials in United States

Canada1 site

  • Sphinx Orthodontics

    Edmonton, Alberta, T5K 2L2

Other trials in Canada

About this study

Official title: OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study

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 products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.

Conditions
Malocclusion
Being tested
OrthoPulse 2.0, OrthoPulse 2.1, Invisalign 3.5 Day Wear, Fixed Orthodontic Appliances (Braces)
Keywords
Malocclusion, Photobiomodulation, Biolux, OrthoPulse, Low-level laser therapy, Orthodontics
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrthoPulse 2.0Device

    Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.

  • OrthoPulse 2.1Device

    Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.

  • Invisalign 3.5 Day WearDevice

    Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.

  • Fixed Orthodontic Appliances (Braces)Device

    Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).

Study groups in NCT03683017
Study groupRoleWhat they receive
I-OP2.0ExperimentalPatients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Receives: Device: OrthoPulse 2.0; Device: Invisalign 3.5 Day Wear
I-OP2.1ExperimentalPatients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
Receives: Device: OrthoPulse 2.1; Device: Invisalign 3.5 Day Wear
F-OP2.0ExperimentalPatients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Receives: Device: OrthoPulse 2.0; Device: Fixed Orthodontic Appliances (Braces)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feedback on general experience

    Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.

    Measured: Through Study Completion, approx. 2 years

  2. Feedback on clinical performance

    Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.

    Measured: Through Study Completion, approx. 2 years

  3. Adverse events

    Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1

    Measured: Through Study Completion, approx. 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start22 Dec 2017
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683017
Sponsor's protocol ID
BX13
Acronym
BX13
Status last verified
Oct 2019
First submitted
27 Feb 2018
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Saito S, Shimizu N. Stimulatory effects of low-power laser irradiation on bone regeneration in midpalatal suture during expansion in the rat. Am J Orthod Dentofacial Orthop. 1997 May;111(5):525-32. doi: 10.1016/s0889-5406(97)70152-5.

    PubMed 9155812

  • Sun X, Zhu X, Xu C, Ye N, Zhu H. [Effects of low energy laser on tooth movement and remodeling of alveolar bone in rabbits]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2001 Oct;19(5):290-3. Chinese.

    PubMed 12539482

  • Yamaguchi M, Hayashi M, Fujita S, Yoshida T, Utsunomiya T, Yamamoto H, Kasai K. Low-energy laser irradiation facilitates the velocity of tooth movement and the expressions of matrix metalloproteinase-9, cathepsin K, and alpha(v) beta(3) integrin in rats. Eur J Orthod. 2010 Apr;32(2):131-9. doi: 10.1093/ejo/cjp078. Epub 2010 Feb 16.

    PubMed 20159792

  • Nimeri G, Kau CH, Corona R, Shelly J. The effect of photobiomodulation on root resorption during orthodontic treatment. Clin Cosmet Investig Dent. 2014 Jan 15;6:1-8. doi: 10.2147/CCIDE.S49489. eCollection 2014.

    PubMed 24470774

  • Ekizer A, Uysal T, Guray E, Akkus D. Effect of LED-mediated-photobiomodulation therapy on orthodontic tooth movement and root resorption in rats. Lasers Med Sci. 2015 Feb;30(2):779-85. doi: 10.1007/s10103-013-1405-3. Epub 2013 Aug 29.

    PubMed 23990217

  • Ekizer A, Uysal T, Guray E, Yuksel Y. Light-emitting diode photobiomodulation: effect on bone formation in orthopedically expanded suture in rats--early bone changes. Lasers Med Sci. 2013 Sep;28(5):1263-70. doi: 10.1007/s10103-012-1214-0. Epub 2012 Nov 9.

    PubMed 23139069

  • El-Bialy T, Alhadlaq A, Felemban N, Yeung J, Ebrahim A, Hassan AH. The effect of light-emitting diode and laser on mandibular growth in rats. Angle Orthod. 2015 Mar;85(2):233-8. doi: 10.2319/030914-170.1. Epub 2014 Jul 14.

    PubMed 25017014

  • Uysal T, Ekizer A, Akcay H, Etoz O, Guray E. Resonance frequency analysis of orthodontic miniscrews subjected to light-emitting diode photobiomodulation therapy. Eur J Orthod. 2012 Feb;34(1):44-51. doi: 10.1093/ejo/cjq166. Epub 2010 Dec 27.

    PubMed 21187526

  • Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.

    PubMed 24326198

  • Shaughnessy T, Kantarci A, Kau CH, Skrenes D, Skrenes S, Ma D. Intraoral photobiomodulation-induced orthodontic tooth alignment: a preliminary study. BMC Oral Health. 2016 Jan 13;16:3. doi: 10.1186/s12903-015-0159-7.

    PubMed 26762247

  • Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.

    PubMed 22381489

  • Dias FJ, Issa JP, Vicentini FT, Fonseca MJ, Leao JC, Siessere S, Regalo SC, Iyomasa MM. Effects of low-level laser therapy on the oxidative metabolism and matrix proteins in the rat masseter muscle. Photomed Laser Surg. 2011 Oct;29(10):677-84. doi: 10.1089/pho.2010.2879. Epub 2011 Jul 11.

    PubMed 21745137

  • Silveira PC, Silva LA, Fraga DB, Freitas TP, Streck EL, Pinho R. Evaluation of mitochondrial respiratory chain activity in muscle healing by low-level laser therapy. J Photochem Photobiol B. 2009 May 4;95(2):89-92. doi: 10.1016/j.jphotobiol.2009.01.004. Epub 2009 Jan 21.

    PubMed 19232497

  • Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.

    PubMed 15334614

  • Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.

    PubMed 17361391

Questions about this trial

What is this clinical trial studying?

A study testing OrthoPulse 2.0, OrthoPulse 2.1 and Invisalign 3.5 Day Wear in people with Malocclusion, run by Biolux Research Holdings, Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feedback on general experience (time frame: Through Study Completion, approx. 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683017, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.

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