NCT02267824

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

October 10, 2014

Results QC Date

February 15, 2016

Last Update Submit

August 23, 2018

Conditions

Malocclusion

Keywords

Alignment phasePhotobiomodulationOrthodontic treatmentMalocclusionOrthoPulse™

Outcome Measures

Primary Outcomes (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.

    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.

Study Arms (2)

Extraoral OrthoPulse® PBM

EXPERIMENTAL

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.

Device: Extraoral OrthoPulse® PBMOther: Fixed Orthodontic Appliance Treatment

Orthodontic Treatment (Control)

OTHER

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.

Other: Fixed Orthodontic Appliance Treatment

Interventions

Extraoral OrthoPulse® PBMDEVICE

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

Extraoral OrthoPulse® PBM
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.

Extraoral OrthoPulse® PBMOrthodontic Treatment (Control)

Eligibility Criteria

Age11 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Orthodontics, School of Dentistry, University of Alabama

Birmingham, Alabama, 35233, United States

Location

Shaughnessy Orthodontics

Suwanee, Georgia, 30024, United States

Location

Clinique Dentaire Alvaro de la Fuente

L'Ile Perrot, Quebec, J7V 4X4, Canada

Location

Department of Orthodontics, Faculty of Dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (19)

  • 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.

    PMID: 24470774BACKGROUND

  • 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.

    PMID: 23990217BACKGROUND

  • 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.

    PMID: 23139069BACKGROUND

  • 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.

    PMID: 21187526BACKGROUND

  • 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.

    PMID: 25017014BACKGROUND

  • 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.

    PMID: 24326198BACKGROUND

  • 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.

    PMID: 21745137BACKGROUND

  • 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.

    PMID: 19232497BACKGROUND

  • 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.

    PMID: 15334614BACKGROUND

  • 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.

    PMID: 21626017BACKGROUND

  • 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.

    PMID: 17361391BACKGROUND

  • 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.

    PMID: 21254890BACKGROUND

  • 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.

    PMID: 24984620BACKGROUND

  • 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.

    PMID: 11776448BACKGROUND

  • 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.

    PMID: 16503787BACKGROUND

  • 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.

    PMID: 9155812BACKGROUND

  • Masha RT, Houreld NN, Abrahamse H. Low-intensity laser irradiation at 660 nm stimulates transcription of genes involved in the electron transport chain. Photomed Laser Surg. 2013 Feb;31(2):47-53. doi: 10.1089/pho.2012.3369. Epub 2012 Dec 16.

    PMID: 23240874BACKGROUND

  • Oron U, Ilic S, De Taboada L, Streeter J. Ga-As (808 nm) laser irradiation enhances ATP production in human neuronal cells in culture. Photomed Laser Surg. 2007 Jun;25(3):180-2. doi: 10.1089/pho.2007.2064.

    PMID: 17603858BACKGROUND

  • 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.

    PMID: 12539482BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Timothy Shaughnessy
Organization
Shaughnessy Orthodontics
staff@straightteethdoc.com
770-495-9590

Study Officials

  • Chung H Kau, DDS

    University of Alabama (UAB) Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 20, 2014

Study Start

December 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 27, 2018

Results First Posted

March 15, 2016

Record last verified: 2018-08

Locations

TH(1)US(2)CA(1)