Back to resultsOrthoPulse 2.0 and 2.1 Feasibility Evaluation (BX13)
Primary Purpose
Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OrthoPulse 2.0
OrthoPulse 2.1
Invisalign 3.5 Day Wear
Fixed Orthodontic Appliances (Braces)
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Malocclusion, Photobiomodulation, Biolux, OrthoPulse, Low-level laser therapy, Orthodontics
Eligibility Criteria
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
Sites / Locations
- Dickerson Orthodontics
- Dickerson Orthodontics
- Dickerson Orthodontics
- Dickerson Orthodontics
- Bella Smile
- Chenin Orthodontics
- Sphinx Orthodontics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
I-OP2.0
I-OP2.1
F-OP2.0
Arm Description
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Outcomes
Primary Outcome Measures
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.
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.
Adverse events
Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1
Secondary Outcome Measures
Full Information
NCT ID
NCT03683017
First Posted
February 27, 2018
Last Updated
October 21, 2019
Sponsor
Biolux Research Holdings, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03683017
Brief Title
OrthoPulse 2.0 and 2.1 Feasibility Evaluation
Acronym
BX13
Official Title
OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolux Research Holdings, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Malocclusion, Photobiomodulation, Biolux, OrthoPulse, Low-level laser therapy, Orthodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-OP2.0
Arm Type
Experimental
Arm Description
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Arm Title
I-OP2.1
Arm Type
Experimental
Arm Description
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
Arm Title
F-OP2.0
Arm Type
Experimental
Arm Description
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Intervention Type
Device
Intervention Name(s)
OrthoPulse 2.0
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
OrthoPulse 2.1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Invisalign 3.5 Day Wear
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed Orthodontic Appliances (Braces)
Intervention Description
Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).
Primary Outcome Measure Information:
Title
Feedback on general experience
Description
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.
Time Frame
Through Study Completion, approx. 2 years
Title
Feedback on clinical performance
Description
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.
Time Frame
Through Study Completion, approx. 2 years
Title
Adverse events
Description
Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1
Time Frame
Through Study Completion, approx. 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Brawn, DDS
Organizational Affiliation
Biolux Research Holdings, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dickerson Orthodontics
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Dickerson Orthodontics
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85382
Country
United States
Facility Name
Dickerson Orthodontics
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Dickerson Orthodontics
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Bella Smile
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Chenin Orthodontics
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Sphinx Orthodontics
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 2L2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9155812
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. doi: 10.1016/s0889-5406(97)70152-5.
Results Reference
background
PubMed Identifier
12539482
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.
Results Reference
background
PubMed Identifier
20159792
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.
Results Reference
background
PubMed Identifier
24470774
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.
Results Reference
background
PubMed Identifier
23990217
Citation
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.
Results Reference
background
PubMed Identifier
23139069
Citation
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.
Results Reference
background
PubMed Identifier
25017014
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.
Results Reference
background
PubMed Identifier
21187526
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.
Results Reference
background
PubMed Identifier
24326198
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.
Results Reference
background
PubMed Identifier
26762247
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.
Results Reference
background
PubMed Identifier
22381489
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.
Results Reference
background
PubMed Identifier
21745137
Citation
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.
Results Reference
background
PubMed Identifier
19232497
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.
Results Reference
background
PubMed Identifier
15334614
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. doi: 10.1002/lsm.20076.
Results Reference
background
PubMed Identifier
17361391
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. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.
Results Reference
background
PubMed Identifier
21254890
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.
Results Reference
background
PubMed Identifier
11776448
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. doi: 10.1089/104454701753342758.
Results Reference
background
PubMed Identifier
16503787
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. doi: 10.1089/pho.2006.24.38.
Results Reference
background
PubMed Identifier
17603858
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. doi: 10.1089/pho.2007.2064.
Results Reference
background
PubMed Identifier
23240874
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.
Results Reference
background
PubMed Identifier
28646819
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. No abstract available.
Results Reference
background
PubMed Identifier
27161014
Citation
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.
Results Reference
background
PubMed Identifier
27323274
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. No abstract available.
Results Reference
background
PubMed Identifier
26799997
Citation
Shaughnessy TG. Long-Distance Orthodontic Treatment with Adjunctive Light Therapy. J Clin Orthod. 2015 Dec;49(12):757-69. No abstract available.
Results Reference
background
PubMed Identifier
25865533
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(0 1):50-61. doi: 10.1111/ocr.12081.
Results Reference
background
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OrthoPulse 2.0 and 2.1 Feasibility Evaluation
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