NCT02954133

Brief Summary

The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

October 31, 2016

Last Update Submit

January 14, 2019

Conditions

Malocclusion

Keywords

Alignment phasePhotobiomodulationOrthodontic treatmentMalocclusionOrthoPulse™Invisalign

Outcome Measures

Primary Outcomes (1)

  • Rate of tooth movement

    Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.

    From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years

Secondary Outcomes (2)

  • Length of treatment time

    From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years

  • Effect of photobiomodulation on external apical root resorption

    From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years

Study Arms (4)

I7: Control

EXPERIMENTAL

Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.

Device: Invisalign (7 day)

OP7: OrthoPulse Treatment

EXPERIMENTAL

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.

Device: Invisalign (7 day)Device: OrthoPulse

OP5: OrthoPulse Treatment

EXPERIMENTAL

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.

Device: Invisalign (5 day)Device: OrthoPulse

OP3.5: OrthoPulse Treatment

EXPERIMENTAL

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.

Device: OrthoPulseDevice: Invisalign (3.5 day)

Interventions

Invisalign (7 day)DEVICE

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.

I7: ControlOP7: OrthoPulse Treatment
Invisalign (5 day)DEVICE

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.

OP5: OrthoPulse Treatment
OrthoPulseDEVICE

Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.

OP3.5: OrthoPulse TreatmentOP5: OrthoPulse TreatmentOP7: OrthoPulse Treatment
Invisalign (3.5 day)DEVICE

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.

OP3.5: OrthoPulse Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Invisalign "Full Treatment" product only
  • Have a permanent dentition
  • years-old
  • Angle Class I or ½ cusp Class II molar and canine relationship
  • Moderate to mild crowding in at least one arch

You may not qualify if:

  • Craniofacial anomaly present
  • Past or present signs and symptoms of periodontal disease
  • A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • Previous orthodontic or orthopedic relapse within 1 year
  • History of trauma, bruxism, or parafunction
  • Skeletal jaw discrepancy
  • Use of osteoporosis drugs
  • Initial use of auxiliary mechanics such as elastics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dickerson Orthodontics

Chandler, Arizona, 85224, United States

Location

Kottemann Orthodontics

Maple Grove, Minnesota, 55369, United States

Location

Chenin Orthodontics

Henderson, Nevada, 89052, United States

Location

Orthodontic Associates

Oklahoma City, Oklahoma, 73120, United States

Location

Related Publications (19)

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    PMID: 12539482BACKGROUND

  • 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.

    PMID: 9155812BACKGROUND

  • 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.

    PMID: 20159792BACKGROUND

  • 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

  • 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.

    PMID: 23990217BACKGROUND

  • 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.

    PMID: 23139069BACKGROUND

  • 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.

    PMID: 25017014BACKGROUND

  • 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.

    PMID: 21187526BACKGROUND

  • 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

  • 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.

    PMID: 26762247BACKGROUND

  • 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.

    PMID: 22381489BACKGROUND

  • 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.

    PMID: 21745137BACKGROUND

  • 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.

    PMID: 19232497BACKGROUND

  • 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

  • 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

  • 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.

    PMID: 11776448BACKGROUND

  • 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.

    PMID: 16503787BACKGROUND

  • 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.

    PMID: 17603858BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Peter Brawn, DDS

    Biolux Research

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 3, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

US(4)