OrthoPulse 2.0 and 2.1 Feasibility Evaluation

Malocclusion Clinical Trial

— BX13  

Official title:

OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03683017
• Other study ID #: BX13
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: Biolux Research Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• OrthoPulse 2.0
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.
• OrthoPulse 2.1
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
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)
Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).

Locations

Country	Name	City	State
Canada	Sphinx Orthodontics	Edmonton	Alberta
United States	Dickerson Orthodontics	Chandler	Arizona
United States	Chenin Orthodontics	Henderson	Nevada
United States	Dickerson Orthodontics	Peoria	Arizona
United States	Dickerson Orthodontics	Phoenix	Arizona
United States	Bella Smile	San Francisco	California
United States	Dickerson Orthodontics	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biolux Research Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (25)

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. Review. — View Citation

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. — View Citation

Dias FJ, Issa JP, Vicentini FT, Fonseca MJ, Leão JC, Siéssere 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. — View Citation

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. — View Citation

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. — View Citation

Ekizer A, Uysal T, Güray 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. — View Citation

Ekizer A, Uysal T, Güray E, Yüksel 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. — View Citation

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. Erratum in: Angle Orthod. 2016 Jan;86(1):177. — View Citation

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 1:50-61. doi: 10.1111/ocr.12081. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shaughnessy TG. Long-Distance Orthodontic Treatment with Adjunctive Light Therapy. J Clin Orthod. 2015 Dec;49(12):757-69. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Mar 15. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adverse events	Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1	Through Study Completion, approx. 2 years