NCT02267811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 21, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

October 10, 2014

Results QC Date

February 24, 2019

Last Update Submit

May 17, 2019

Conditions

Malocclusion

Keywords

PhotobiomodulationOrthodontic treatmentMalocclusionOrthoPulse™

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Safety Evidence of OrthoPulse™ Use

    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.

  • Degree of External Apical Root Resorption (EARR)

    Assessed at six (6) months or later after starting treatment, up to two (2) years.

Study Arms (2)

Fixed Orthodontic Treatment with OrthoPulse™

EXPERIMENTAL

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

Other: Orthodontic TreatmentDevice: OrthoPulse™

Fixed Orthodontic Treatment

EXPERIMENTAL

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

Other: Orthodontic Treatment

Interventions

Orthodontic TreatmentOTHER

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.

Fixed Orthodontic TreatmentFixed Orthodontic Treatment with OrthoPulse™
OrthoPulse™DEVICE

Participants carry out daily OrthoPulse™ treatments at home.

Fixed Orthodontic Treatment with OrthoPulse™

Eligibility Criteria

Age11 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stone Oak Orthodontics

San Antonio, Texas, 78232, United States

Location

Related Publications (34)

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    PMID: 12737218BACKGROUND

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    PMID: 11668873BACKGROUND

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    PMID: 17208099BACKGROUND

  • 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.

    PMID: 8060014BACKGROUND

  • 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.

    PMID: 6243447BACKGROUND

  • 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.

    PMID: 18405822BACKGROUND

  • 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.

    PMID: 16648212BACKGROUND

  • 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.

    PMID: 1059332BACKGROUND

  • 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.

    PMID: 24326198BACKGROUND

  • 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.

    PMID: 21254890BACKGROUND

  • 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.

    PMID: 15334614BACKGROUND

  • 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.

    PMID: 17361391BACKGROUND

  • 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.

    PMID: 16420273BACKGROUND

  • 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.

    PMID: 21130338BACKGROUND

  • 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.

    PMID: 12637908BACKGROUND

  • 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.

    PMID: 24094011BACKGROUND

  • 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.

    PMID: 23941626BACKGROUND

  • 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.

    PMID: 14628135BACKGROUND

  • 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.

    PMID: 12013568BACKGROUND

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    PMID: 14994886BACKGROUND

  • 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.

    PMID: 1456222BACKGROUND

  • 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.

    PMID: 21300250BACKGROUND

  • 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.

    PMID: 18174067BACKGROUND

  • 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.

    PMID: 18753305BACKGROUND

  • 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.

    PMID: 24470774BACKGROUND

  • 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.

    PMID: 6578039BACKGROUND

  • 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.

    PMID: 21919826BACKGROUND

  • 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.

    PMID: 23092202BACKGROUND

  • 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.

    PMID: 14558871BACKGROUND

  • 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.

    PMID: 21875995BACKGROUND

  • 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.

    PMID: 23299650BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Results Point of Contact

Title
Dr. Peter Brawn
Organization
Biolux Research, Ltd.
p.brawn@bioluxresearch.com
6046690674

Study Officials

  • Peter Brawn, DDS

    Biolux Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 20, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 21, 2019

Results First Posted

May 21, 2019

Record last verified: 2019-05

Locations

US(1)