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OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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 Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

Eligibility Criteria

11 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of permanent dentition
  • Eligible and scheduled for full mouth fixed orthodontic treatment
  • Class I or Class II malocclusion (no more than ½ cusp in Class II)
  • Non-extraction in all quadrants
  • Non-smoker
  • Good oral hygiene as determined by the investigator
  • No adjunct treatment such as extra- or intra-oral appliances

Exclusion Criteria:

  • Pregnant females
  • Patient is currently enrolled in another clinical study
  • Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
  • Periodontally involved teeth
  • Use of bisphosphonates
  • Unerupted or partially erupted maxillary teeth
  • Teeth blocked out of alignment and unable to engage initial arch wire
  • Spaces present in the maxillary arch

Sites / Locations

  • Shaughnessy Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OrthoPulse™

Control

Arm Description

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

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.

Outcomes

Primary Outcome Measures

Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2014
Last Updated
August 23, 2018
Sponsor
Biolux Research Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02267837
Brief Title
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Official Title
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolux Research Holdings, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Alignment phase, 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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OrthoPulse™
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Intervention Type
Device
Intervention Name(s)
OrthoPulse™
Intervention Description
Patients carry out daily OrthoPulse™ treatments at home.
Primary Outcome Measure Information:
Title
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
Time Frame
Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of permanent dentition Eligible and scheduled for full mouth fixed orthodontic treatment Class I or Class II malocclusion (no more than ½ cusp in Class II) Non-extraction in all quadrants Non-smoker Good oral hygiene as determined by the investigator No adjunct treatment such as extra- or intra-oral appliances Exclusion Criteria: Pregnant females Patient is currently enrolled in another clinical study Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) Periodontally involved teeth Use of bisphosphonates Unerupted or partially erupted maxillary teeth Teeth blocked out of alignment and unable to engage initial arch wire Spaces present in the maxillary arch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Shaughnessy, DDS
Organizational Affiliation
Shaughnessy Orthodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaughnessy Orthodontics
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States

12. IPD Sharing Statement

Citations:
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
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
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
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
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
21626017
Citation
Esper MA, Nicolau RA, Arisawa EA. The effect of two phototherapy protocols on pain control in orthodontic procedure--a preliminary clinical study. Lasers Med Sci. 2011 Sep;26(5):657-63. doi: 10.1007/s10103-011-0938-6. Epub 2011 May 31.
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
24984620
Citation
Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.
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
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
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
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
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
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
derived

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OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

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