The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
NCT ID: NCT03202355
Last Updated: 2019-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2017-04-20
2019-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Control)
Subjects assigned to this group receive fixed appliance orthodontic treatment only
Fixed Appliance Orthodontic Treatment
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Group 2 (OP1)
Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Fixed Appliance Orthodontic Treatment
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
Interventions
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Fixed Appliance Orthodontic Treatment
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
Eligibility Criteria
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Inclusion Criteria
* Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
* Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
* Class I or Class II malocclusion by ½ cusp or less
* Non-extraction in both arches
* Age 11-60
* Good oral hygiene
* Non-smoker; non-use of chewing tobacco
Exclusion Criteria
* Subject decided on Invisalign rather than braces
* Periodontally involved teeth
* Use of bisphosphonates (osteoporosis drugs) during the study
* Subject plans to relocate over the treatment period
* Spaces between anterior teeth
* Subject has dental implants or an implanted prosthesis
* Sponsor employees, the Investigator and staff, as well as their immediate family members
11 Years
60 Years
ALL
Yes
Sponsors
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Biolux Research Holdings, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Brawn, DDS
Role: STUDY_DIRECTOR
Biolux Research Holdings, Inc.
Locations
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Dickerson Orthodontics
Chandler, Arizona, United States
Dickerson Orthodontics
Peoria, Arizona, United States
Dickerson Orthodontics
Phoenix, Arizona, United States
Countries
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References
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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.
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.
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.
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.
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.
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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.
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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.
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.
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.
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.
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.
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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.
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Other Identifiers
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BX11
Identifier Type: -
Identifier Source: org_study_id
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