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MalocclusionNCT02267824

The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

A study testing Extraoral OrthoPulse® PBM and Fixed Orthodontic Appliance Treatment in people with Malocclusion, run by Biolux Research Holdings, Inc. at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment. Read more about this study

Who is it for?
Ages 11 to 40 years
Conditions the study is for
Malocclusion
What is being tested?
Extraoral OrthoPulse® PBM and Fixed Orthodontic Appliance Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
4 sitesin 3 countries
Study dates
Dec 2010to Mar 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Permanent dentition
  • Class I malocclusion with irregularity score of greater than 2 mm in either arch
  • Good oral hygiene

Who cannot join

  • Any medical or dental condition that could potentially affect study results
  • Patients currently using any investigational drug or any other investigational device
  • Patients planning to relocate or move during the treatment period
  • Use of bisphosphonates
  • Pregnant females

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • Department of Orthodontics, School of Dentistry, University of Alabama

    Birmingham, Alabama, 35233

  • Shaughnessy Orthodontics

    Suwanee, Georgia, 30024

Other trials in United States

Canada1 site

  • Clinique Dentaire Alvaro de la Fuente

    L'Ile Perrot, Quebec, J7V 4X4

Other trials in Canada

Thailand1 site

  • Department of Orthodontics, Faculty of Dentistry, Mahidol University

    Bangkok, 10400

Other trials in Thailand

About this study

The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.

Conditions
Malocclusion
Being tested
Extraoral OrthoPulse® PBM, Fixed Orthodontic Appliance Treatment
Keywords
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Medical subject headings
Malocclusion

What participants receive

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

  • Extraoral OrthoPulse® PBMDevice

    Patients carry out daily extraoral OrthoPulse® PBM treatments at home.

  • Fixed Orthodontic Appliance TreatmentOther

    Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.

Study groups in NCT02267824
Study groupRoleWhat they receive
Extraoral OrthoPulse® PBMExperimentalSubjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
Receives: Device: Extraoral OrthoPulse® PBM; Other: Fixed Orthodontic Appliance Treatment
Orthodontic Treatment (Control)OtherSubjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
Receives: Other: Fixed Orthodontic Appliance Treatment

What is being measured

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

  1. Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.

    Measured: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.

Timeline

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

  1. First posted20 Oct 2014 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267824
Sponsor's protocol ID
OP2
Status last verified
Aug 2018
First submitted
10 Oct 2014
Last updated
27 Aug 2018
Data monitoring committee
No

Publications

  • 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

  • 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

  • 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

  • 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

  • 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

  • Esper MA, Nicolau RA, Arisawa EA. The effect of two phototherapy protocols on pain control in orthodontic procedure--a preliminary clinical study. Lasers Med Sci. 2011 Sep;26(5):657-63. doi: 10.1007/s10103-011-0938-6. Epub 2011 May 31.

    PubMed 21626017

  • 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

  • Sousa MV, Scanavini MA, Sannomiya EK, Velasco LG, Angelieri F. Influence of low-level laser on the speed of orthodontic movement. Photomed Laser Surg. 2011 Mar;29(3):191-6. doi: 10.1089/pho.2009.2652. Epub 2011 Jan 23.

    PubMed 21254890

  • Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.

    PubMed 24984620

  • Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.

    PubMed 11776448

  • Weber JB, Pinheiro AL, de Oliveira MG, Oliveira FA, Ramalho LM. Laser therapy improves healing of bone defects submitted to autologous bone graft. Photomed Laser Surg. 2006 Feb;24(1):38-44. doi: 10.1089/pho.2006.24.38.

    PubMed 16503787

Questions about this trial

What is this clinical trial studying?

A study testing Extraoral OrthoPulse® PBM and Fixed Orthodontic Appliance Treatment in people with Malocclusion, run by Biolux Research Holdings, Inc. at 4 sites in 3 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada, Thailand. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. (time frame: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.). 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 NCT02267824, which also lists 19 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 27 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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