search
Back to results

The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances

Primary Purpose

Malocclusion

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

Eligibility Criteria

11 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Presence of permanent dentition
  • 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 is currently enrolled in another clinical study
  • 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

Sites / Locations

  • Dickerson Orthodontics
  • Dickerson Orthodontics
  • Dickerson Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 (Control)

Group 2 (OP1)

Arm Description

Subjects assigned to this group receive fixed appliance orthodontic treatment only

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

Outcomes

Primary Outcome Measures

Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator.

Secondary Outcome Measures

Effect of OrthoPulse PBM on external apical root resorption (EARR)
Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups.
Risk of OrthoPulse PBM to the patient.
Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events.

Full Information

First Posted
June 19, 2017
Last Updated
April 4, 2019
Sponsor
Biolux Research Holdings, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03202355
Brief Title
The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
Official Title
The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated due to clinical staffing changes and enrolment
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
March 11, 2019 (Actual)
Study Completion Date
March 11, 2019 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.

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
Model Description
This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Control)
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive fixed appliance orthodontic treatment only
Arm Title
Group 2 (OP1)
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Intervention Type
Device
Intervention Name(s)
Fixed Appliance Orthodontic Treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
OrthoPulse™
Intervention Description
Patients carry out daily OrthoPulse™ treatments at home.
Primary Outcome Measure Information:
Title
Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
Description
Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator.
Time Frame
From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment.
Secondary Outcome Measure Information:
Title
Effect of OrthoPulse PBM on external apical root resorption (EARR)
Description
Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups.
Time Frame
6 months after the start of orthodontic treatment
Title
Risk of OrthoPulse PBM to the patient.
Description
Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of permanent dentition 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 is currently enrolled in another clinical study 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
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

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

Learn more about this trial

The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances

We'll reach out to this number within 24 hrs