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The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement (BX8RN)

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthodontic Treatment
OrthoPulse™
Sponsored by
Biolux Research Holdings, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

Eligibility Criteria

11 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible and scheduled for full mouth fixed orthodontic treatment
  • Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
  • Class I or Class II by 1/2 cusp or less
  • Non-extraction in both arches
  • Age 11- 60
  • Good oral hygiene
  • Non-smokerInclud

Exclusion Criteria:

  • Pregnant females
  • Patient is currently enrolled in another clinical study
  • Patient decided on Invisalign® rather than braces
  • Periodontally involved teeth
  • Use of bisphosphonates (osteoporosis drugs) during the study
  • Patient plans to move over the treatment period
  • Spaces between anterior teeth

Sites / Locations

  • Stone Oak Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fixed Orthodontic Treatment with OrthoPulse™

Fixed Orthodontic Treatment

Arm Description

Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.

Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety Evidence of OrthoPulse™ Use
The number of significant adverse events reported from time of participant enrolment to study completion for all study participants
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.

Full Information

First Posted
October 10, 2014
Last Updated
May 17, 2019
Sponsor
Biolux Research Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02267811
Brief Title
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Acronym
BX8RN
Official Title
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed Orthodontic Treatment with OrthoPulse™
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Arm Title
Fixed Orthodontic Treatment
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.
Intervention Type
Other
Intervention Name(s)
Orthodontic Treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
OrthoPulse™
Intervention Description
Participants carry out daily OrthoPulse™ treatments at home.
Primary Outcome Measure Information:
Title
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
Description
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
Time Frame
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 Outcome Measure Information:
Title
Safety Evidence of OrthoPulse™ Use
Description
The number of significant adverse events reported from time of participant enrolment to study completion for all study participants
Time Frame
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.
Title
Degree of External Apical Root Resorption (EARR)
Description
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.
Time Frame
Assessed at six (6) months or later after starting treatment, up to two (2) years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible and scheduled for full mouth fixed orthodontic treatment Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth Class I or Class II by 1/2 cusp or less Non-extraction in both arches Age 11- 60 Good oral hygiene Non-smokerInclud Exclusion Criteria: Pregnant females Patient is currently enrolled in another clinical study Patient decided on Invisalign® rather than braces Periodontally involved teeth Use of bisphosphonates (osteoporosis drugs) during the study Patient plans to move over the treatment period Spaces between anterior teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Brawn, DDS
Organizational Affiliation
Biolux Research
Official's Role
Study Director
Facility Information:
Facility Name
Stone Oak Orthodontics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16473715
Citation
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.
Results Reference
background
PubMed Identifier
15490263
Citation
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.
Results Reference
background
PubMed Identifier
6587784
Citation
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.
Results Reference
background
PubMed Identifier
12737218
Citation
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.
Results Reference
background
PubMed Identifier
11668873
Citation
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.
Results Reference
background
PubMed Identifier
17208099
Citation
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.
Results Reference
background
PubMed Identifier
8060014
Citation
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.
Results Reference
background
PubMed Identifier
6243447
Citation
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.
Results Reference
background
PubMed Identifier
18405822
Citation
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.
Results Reference
background
PubMed Identifier
16648212
Citation
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.
Results Reference
background
PubMed Identifier
1059332
Citation
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.
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
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
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
16420273
Citation
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.
Results Reference
background
PubMed Identifier
21130338
Citation
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.
Results Reference
background
PubMed Identifier
12637908
Citation
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.
Results Reference
background
PubMed Identifier
24094011
Citation
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.
Results Reference
background
PubMed Identifier
23941626
Citation
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.
Results Reference
background
PubMed Identifier
14628135
Citation
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.
Results Reference
background
PubMed Identifier
12013568
Citation
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.
Results Reference
background
PubMed Identifier
14994886
Citation
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.
Results Reference
background
PubMed Identifier
1456222
Citation
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.
Results Reference
background
PubMed Identifier
21300250
Citation
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.
Results Reference
background
PubMed Identifier
18174067
Citation
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.
Results Reference
background
PubMed Identifier
18753305
Citation
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.
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
6578039
Citation
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.
Results Reference
background
PubMed Identifier
21919826
Citation
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.
Results Reference
background
PubMed Identifier
23092202
Citation
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.
Results Reference
background
PubMed Identifier
14558871
Citation
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.
Results Reference
background
PubMed Identifier
21875995
Citation
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. Erratum In: J Orthod. 2011 Dec;38(4):309.
Results Reference
background
PubMed Identifier
23299650
Citation
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.
Results Reference
background

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The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

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