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This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.
The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.
The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.
The study also aims to collect confirmatory evidence on the safety of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Orthodontic Treatment with OrthoPulse™ | Experimental | Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. |
|
| Fixed Orthodontic Treatment | Experimental | Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthodontic Treatment | Other | Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment. | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evidence of OrthoPulse™ Use | The number of significant adverse events reported from time of participant enrolment to study completion for all study participants | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Brawn, DDS | Biolux Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stone Oak Orthodontics | San Antonio | Texas | 78232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16473715 | Background | Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003. | |
| 15490263 | Background | Kawakami M, Takano-Yamamoto T. Local injection of 1,25-dihydroxyvitamin D3 enhanced bone formation for tooth stabilization after experimental tooth movement in rats. J Bone Miner Metab. 2004;22(6):541-6. doi: 10.1007/s00774-004-0521-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. Orthodontic Treatment: Patients are treated for 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. |
| FG001 | BX8RN: Orthodontic Treatment (Control) | Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment. Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BX8RN: OrthoPulse™ (Treatment) | Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. Orthodontic Treatment: Patients are treated for 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment. | Posted | Mean | Standard Deviation | millimeters per week | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. |
|
Adverse events were collected at all visits from the time of participant enrolment through the study final visit, two (2) years or less.
The definitions for adverse event and/or serious adverse event used in this study do not differ from ClinicalTrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fixed Orthodontic Treatment With OrthoPulse™ (Treatment) | Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. Orthodontic Treatment: Patients are treated for 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Brawn | Biolux Research, Ltd. | 6046690674 | p.brawn@bioluxresearch.com |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009970 | Orthodontics |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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| OrthoPulse™ | Device | Participants carry out daily OrthoPulse™ treatments at home. |
|
| Degree of External Apical Root Resorption (EARR) |
The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters. A positive number under the measure of dispersion signifies root resorption. |
| Assessed at six (6) months or later after starting treatment, up to two (2) years. |
| 6587784 | Background | Yamasaki K, Shibata Y, Imai S, Tani Y, Shibasaki Y, Fukuhara T. Clinical application of prostaglandin E1 (PGE1) upon orthodontic tooth movement. Am J Orthod. 1984 Jun;85(6):508-18. doi: 10.1016/0002-9416(84)90091-5. |
| 12737218 | Background | Seifi M, Eslami B, Saffar AS. The effect of prostaglandin E2 and calcium gluconate on orthodontic tooth movement and root resorption in rats. Eur J Orthod. 2003 Apr;25(2):199-204. doi: 10.1093/ejo/25.2.199. |
| 11668873 | Background | Hashimoto F, Kobayashi Y, Mataki S, Kobayashi K, Kato Y, Sakai H. Administration of osteocalcin accelerates orthodontic tooth movement induced by a closed coil spring in rats. Eur J Orthod. 2001 Oct;23(5):535-45. doi: 10.1093/ejo/23.5.535. |
| 17208099 | Background | Madan MS, Liu ZJ, Gu GM, King GJ. Effects of human relaxin on orthodontic tooth movement and periodontal ligaments in rats. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):8.e1-10. doi: 10.1016/j.ajodo.2006.06.014. |
| 8060014 | Background | Frost HM. Wolff's Law and bone's structural adaptations to mechanical usage: an overview for clinicians. Angle Orthod. 1994;64(3):175-88. doi: 10.1043/0003-3219(1994)0642.0.CO;2. |
| 6243447 | Background | Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. I. The effect of electric currents on periodontal cyclic nucleotides. Am J Orthod. 1980 Jan;77(1):14-32. doi: 10.1016/0002-9416(80)90221-3. |
| 18405822 | Background | Nishimura M, Chiba M, Ohashi T, Sato M, Shimizu Y, Igarashi K, Mitani H. Periodontal tissue activation by vibration: intermittent stimulation by resonance vibration accelerates experimental tooth movement in rats. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):572-83. doi: 10.1016/j.ajodo.2006.01.046. |
| 16648212 | Background | Bernabe E, Flores-Mir C. Estimating arch length discrepancy through Little's Irregularity Index for epidemiological use. Eur J Orthod. 2006 Jun;28(3):269-73. doi: 10.1093/ejo/cji112. Epub 2006 Apr 28. |
| 1059332 | Background | Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x. |
| 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. |
| 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. |
| 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. |
| 16420273 | Background | Limpanichkul W, Godfrey K, Srisuk N, Rattanayatikul C. Effects of low-level laser therapy on the rate of orthodontic tooth movement. Orthod Craniofac Res. 2006 Feb;9(1):38-43. doi: 10.1111/j.1601-6343.2006.00338.x. |
| 21130338 | Background | Almasoud N, Bearn D. Little's irregularity index: photographic assessment vs study model assessment. Am J Orthod Dentofacial Orthop. 2010 Dec;138(6):787-94. doi: 10.1016/j.ajodo.2009.01.031. |
| 12637908 | Background | Tran AM, Rugh JD, Chacon JA, Hatch JP. Reliability and validity of a computer-based Little irregularity index. Am J Orthod Dentofacial Orthop. 2003 Mar;123(3):349-51. doi: 10.1067/mod.2003.76. No abstract available. |
| 24094011 | Background | Canuto LF, de Freitas MR, de Freitas KM, Cancado RH, Neves LS. Long-term stability of maxillary anterior alignment in non-extraction cases. Dental Press J Orthod. 2013 May-Jun;18(3):46-53. doi: 10.1590/s2176-94512013000300009. |
| 23941626 | Background | Krieger E, Drechsler T, Schmidtmann I, Jacobs C, Haag S, Wehrbein H. Apical root resorption during orthodontic treatment with aligners? A retrospective radiometric study. Head Face Med. 2013 Aug 14;9:21. doi: 10.1186/1746-160X-9-21. |
| 14628135 | Background | Fritz U, Diedrich P, Wiechmann D. Apical root resorption after lingual orthodontic therapy. J Orofac Orthop. 2003 Nov;64(6):434-42. doi: 10.1007/s00056-003-0243-5. English, German. |
| 12013568 | Background | Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x. |
| 14994886 | Background | Erdinc AM, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004 Feb;26(1):79-85. doi: 10.1093/ejo/26.1.79. |
| 1456222 | Background | Jones M, Chan C. The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):373-81. doi: 10.1016/0889-5406(92)70054-e. |
| 21300250 | Background | Liu Z, McGrath C, Hagg U. Changes in oral health-related quality of life during fixed orthodontic appliance therapy: an 18-month prospective longitudinal study. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):214-9. doi: 10.1016/j.ajodo.2009.08.029. |
| 18174067 | Background | Zhang M, McGrath C, Hagg U. Changes in oral health-related quality of life during fixed orthodontic appliance therapy. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):25-9. doi: 10.1016/j.ajodo.2007.01.024. |
| 18753305 | Background | Bernabe E, Sheiham A, Tsakos G, Messias de Oliveira C. The impact of orthodontic treatment on the quality of life in adolescents: a case-control study. Eur J Orthod. 2008 Oct;30(5):515-20. doi: 10.1093/ejo/cjn026. Epub 2008 Aug 27. |
| 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. |
| 6578039 | Background | Linge BO, Linge L. Apical root resorption in upper anterior teeth. Eur J Orthod. 1983 Aug;5(3):173-83. doi: 10.1093/ejo/5.3.173. No abstract available. |
| 21919826 | Background | Lund H, Grondahl K, Hansen K, Grondahl HG. Apical root resorption during orthodontic treatment. A prospective study using cone beam CT. Angle Orthod. 2012 May;82(3):480-7. doi: 10.2319/061311-390.1. Epub 2011 Sep 16. |
| 23092202 | Background | Makedonas D, Lund H, Hansen K. Root resorption diagnosed with cone beam computed tomography after 6 months and at the end of orthodontic treatment with fixed appliances. Angle Orthod. 2013 May;83(3):389-93. doi: 10.2319/042012-332.1. Epub 2012 Oct 23. |
| 14558871 | Background | Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust. 2003 Oct 20;179(8):438-40. doi: 10.5694/j.1326-5377.2003.tb05627.x. No abstract available. |
| 21875995 | Background | Wright N, Modarai F, Cobourne MT, Dibiase AT. Do you do Damon(R)? What is the current evidence base underlying the philosophy of this appliance system? J Orthod. 2011 Sep;38(3):222-30. doi: 10.1179/14653121141479. |
| 23299650 | Background | Celar A, Schedlberger M, Dorfler P, Bertl M. Systematic review on self-ligating vs. conventional brackets: initial pain, number of visits, treatment time. J Orofac Orthop. 2013 Jan;74(1):40-51. doi: 10.1007/s00056-012-0116-x. Epub 2013 Jan 10. |
| BG001 | BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) | Subjects assigned to this group receive orthodontic treatment with no daily OrthoPulse™ treatments. Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | BX8RN: Orthodontic Treatment (Control) | Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment. Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. |
|
|
| Secondary | Safety Evidence of OrthoPulse™ Use | The number of significant adverse events reported from time of participant enrolment to study completion for all study participants | Posted | Number | Adverse Events | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. |
|
|
|
| Secondary | Degree of External Apical Root Resorption (EARR) | The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters. A positive number under the measure of dispersion signifies root resorption. | The overall number of participants is not consistent with the number of participants analyzed in this arm because the panoramic radiographs required to analyze the EARR were not available for the remaining 11 participants. | Posted | Mean | Standard Deviation | millimeters | Assessed at six (6) months or later after starting treatment, up to two (2) years. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Fixed Orthodontic Treatment (Control) | Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment. Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. | 0 | 17 | 0 | 17 | 0 | 17 |
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