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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| F-OP2.0 | Experimental | Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Brawn, DDS | Biolux Research Holdings, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dickerson Orthodontics | Chandler | Arizona | 85224 | United States | ||
| Dickerson Orthodontics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9155812 | Background | 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. | |
| 12539482 | 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. |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009968 | Orthodontic Appliances, Removable |
| D000077744 | Orthodontic Appliances, Fixed |
| D001915 | Braces |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
| D009989 | Orthotic Devices |
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| 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. |
|
| 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. |
|
| 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). |
|
| Peoria |
| Arizona |
| 85382 |
| United States |
| Dickerson Orthodontics | Phoenix | Arizona | 85028 | United States |
| Dickerson Orthodontics | Scottsdale | Arizona | 85254 | United States |
| Bella Smile | San Francisco | California | 94118 | United States |
| Chenin Orthodontics | Henderson | Nevada | 89052 | United States |
| Sphinx Orthodontics | Edmonton | Alberta | T5K 2L2 | Canada |
| 20159792 | 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. |
| 24470774 | 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. |
| 23990217 | 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. |
| 23139069 | 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. |
| 25017014 | 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. |
| 21187526 | 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. |
| 24326198 | 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. |
| 26762247 | 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. |
| 22381489 | 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. |
| 21745137 | 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. |
| 19232497 | 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. |
| 15334614 | 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. |
| 17361391 | 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. |
| 21254890 | 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. |
| 11776448 | 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. |
| 16503787 | 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. |
| 17603858 | 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. |
| 23240874 | 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. |
| 28646819 | 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. |
| 27161014 | 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. |
| 27323274 | 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. |
| 26799997 | Background | Shaughnessy TG. Long-Distance Orthodontic Treatment with Adjunctive Light Therapy. J Clin Orthod. 2015 Dec;49(12):757-69. No abstract available. |
| 25865533 | 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. |
| D009983 |
| Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |