OrthoPulse 2.0 and 2.1 Feasibility Evaluation

NCT03683017 | Unknown FDA Device

• 1 other identifier: BX13
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Malocclusion

Keywords

Malocclusion; Photobiomodulation; Biolux; OrthoPulse; Low-level laser therapy; Orthodontics

Outcome Measures

Primary Outcomes (3)

• 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.

  Through Study Completion, approx. 2 years

• 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.

  Through Study Completion, approx. 2 years

• Adverse events

  Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1

  Through Study Completion, approx. 2 years

Study Arms (3)

I-OP2.0

EXPERIMENTAL

Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.

Device: OrthoPulse 2.0; Device: Invisalign 3.5 Day Wear

I-OP2.1

EXPERIMENTAL

Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.

Device: OrthoPulse 2.1; Device: Invisalign 3.5 Day Wear

F-OP2.0

EXPERIMENTAL

Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.

Device: OrthoPulse 2.0; Device: Fixed Orthodontic Appliances (Braces)

Interventions

OrthoPulse 2.0 DEVICE

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.

F-OP2.0; I-OP2.0

OrthoPulse 2.1 DEVICE

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.

I-OP2.1

Invisalign 3.5 Day Wear DEVICE

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.

I-OP2.0; I-OP2.1

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).

F-OP2.0

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Epilepsy
• Patient plans to relocate over the treatment period
• Smoker or use of any tobacco containing products per the discretion of the PI

Sponsors & Collaborators

• Biolux Research Holdings, Inc.: lead

Study Sites (7)

Dickerson Orthodontics

Chandler, Arizona, 85224, United States

Location

Dickerson Orthodontics

Peoria, Arizona, 85382, United States

Location

Dickerson Orthodontics

Phoenix, Arizona, 85028, United States

Location

Dickerson Orthodontics

Scottsdale, Arizona, 85254, United States

Location

Bella Smile

San Francisco, California, 94118, United States

Location

Chenin Orthodontics

Henderson, Nevada, 89052, United States

Location

Sphinx Orthodontics

Edmonton, Alberta, T5K 2L2, Canada

Location

Related Publications (25)

• 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: 9155812 BACKGROUND

• 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: 12539482 BACKGROUND

• 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.

  PMID: 20159792 BACKGROUND

• 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: 24470774 BACKGROUND

• 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: 23990217 BACKGROUND

• 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: 23139069 BACKGROUND

• 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: 25017014 BACKGROUND

• 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: 21187526 BACKGROUND

• 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: 24326198 BACKGROUND

• 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.

  PMID: 26762247 BACKGROUND

• 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.

  PMID: 22381489 BACKGROUND

• 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: 21745137 BACKGROUND

• 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: 19232497 BACKGROUND

• 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: 15334614 BACKGROUND

• 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: 17361391 BACKGROUND

• 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: 21254890 BACKGROUND

• 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: 11776448 BACKGROUND

• 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: 16503787 BACKGROUND

• 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: 17603858 BACKGROUND

• 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: 23240874 BACKGROUND

• Dickerson TE. Invisalign with Photobiomodulation: Optimizing Tooth Movement and Treatment Efficacy with a Novel Self-Assessment Algorithm. J Clin Orthod. 2017 Mar;51(3):157-165. No abstract available.

  PMID: 28646819 BACKGROUND

• Arany PR. Craniofacial Wound Healing with Photobiomodulation Therapy: New Insights and Current Challenges. J Dent Res. 2016 Aug;95(9):977-84. doi: 10.1177/0022034516648939. Epub 2016 May 9.

  PMID: 27161014 BACKGROUND

• Ojima K, Dan C, Kumagai Y, Schupp W. Invisalign Treatment Accelerated by Photobiomodulation. J Clin Orthod. 2016 May;50(5):309-17; quiz 319-20. No abstract available.

  PMID: 27323274 BACKGROUND

• Shaughnessy TG. Long-Distance Orthodontic Treatment with Adjunctive Light Therapy. J Clin Orthod. 2015 Dec;49(12):757-69. No abstract available.

  PMID: 26799997 BACKGROUND

• Guo J, Wang Q, Wai D, Zhang QZ, Shi SH, Le AD, Shi ST, Yen SL. Visible red and infrared light alters gene expression in human marrow stromal fibroblast cells. Orthod Craniofac Res. 2015 Apr;18 Suppl 1(0 1):50-61. doi: 10.1111/ocr.12081.

  PMID: 25865533 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontic Appliances, Removable; Orthodontic Appliances, Fixed; Braces

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Peter Brawn, DDS

  Biolux Research Holdings, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: September 25, 2018
• Study Start: December 22, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)