NCT02267850

Brief Summary

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
1.4 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 27, 2018

Completed
Last Updated

September 21, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

October 10, 2014

Results QC Date

February 27, 2018

Last Update Submit

August 23, 2018

Conditions

Malocclusion

Keywords

PhotobiomodulationOrthodontic treatmentMalocclusionOrthoPulse™

Outcome Measures

Primary Outcomes (1)

  • Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.

    The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.

    Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.

Study Arms (2)

OrthoPulse™

EXPERIMENTAL

Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.

Other: Fixed Orthodontic Appliance TreatmentDevice: OrthoPulse™

Sham-Control OrthoPulse™

SHAM COMPARATOR

Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).

Other: Fixed Orthodontic Appliance TreatmentDevice: Non-Functional OrthoPulse™

Interventions

Fixed Orthodontic Appliance TreatmentOTHER

Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

OrthoPulse™Sham-Control OrthoPulse™
OrthoPulse™DEVICE

Patients carry out daily OrthoPulse™ treatments at home.

OrthoPulse™
Non-Functional OrthoPulse™DEVICE

Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.

Sham-Control OrthoPulse™

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presence of permanent dentition
  • Eligible and scheduled for full mouth fixed orthodontic treatment.
  • Class I or Class II malocclusion (no more than ½ cusp in Class II)
  • Non-extraction in all quadrants
  • Non-smoker, non-use of chewing tobacco
  • Good oral hygiene
  • No adjunct treatment such as extra or intraoral appliances
  • Age 12-40

You may not qualify if:

  • Pregnant females
  • Patient is currently enrolled in another clinical study
  • Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
  • Periodontally involved teeth
  • Use of bisphosphonates
  • Unerupted erupted teeth
  • Teeth blocked out of alignment and unable to engage initial arch wire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaughnessy Orthodontics

Suwanee, Georgia, 30024, United States

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

  • 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

  • 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

  • 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
Clinical Studies Manager
Organization
Biolux Research Ltd
d.skrenes@bioluxresearch.com
1-604-669-0674

Study Officials

  • Timothy Shaughnessy, DDS

    Shaughnessy Orthodontics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
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

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 21, 2018

Results First Posted

March 27, 2018

Record last verified: 2018-02

Locations

US(1)