MalocclusionNCT03202355

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

A study testing Fixed Appliance Orthodontic Treatment and OrthoPulse™ in people with Malocclusion, run by Biolux Research Holdings, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 11 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Malocclusion
What is being tested?: Fixed Appliance Orthodontic Treatment and OrthoPulse™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesUnited States
Study dates: 20 Apr 2017to 11 Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Dickerson Orthodontics
Chandler, Arizona, 85224
Dickerson Orthodontics
Peoria, Arizona, 85382
Dickerson Orthodontics
Phoenix, Arizona, 85028

Other trials in United States

About this study

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.

Conditions: Malocclusion
Being tested: Fixed Appliance Orthodontic Treatment, OrthoPulse™
Keywords: Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed Appliance Orthodontic TreatmentDevice
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.
OrthoPulse™Device
Patients carry out daily OrthoPulse™ treatments at home.

Study groups in NCT03202355
Study group	Role	What they receive
Group 1 (Control)	Experimental	Subjects assigned to this group receive fixed appliance orthodontic treatment only Receives: Device: Fixed Appliance Orthodontic Treatment
Group 2 (OP1)	Experimental	Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. Receives: Device: Fixed Appliance Orthodontic Treatment; Device: OrthoPulse™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 outcomes (2)

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.
Measured: 6 months after the start of orthodontic treatment
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201711 Mar 2019

First posted28 Jun 2017
Study start20 Apr 2017
Primary completion11 Mar 2019
Study completion11 Mar 2019

Why it stopped: Sponsor terminated due to clinical staffing changes and enrolment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for MalocclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03202355
Sponsor's protocol ID: BX11
Status last verified: Apr 2019
First submitted: 19 Jun 2017
Last updated: 8 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 9155812
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.
PubMed 12539482
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.
PubMed 20159792
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.
PubMed 24470774
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.
PubMed 23990217
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.
PubMed 23139069
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.
PubMed 25017014
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.
PubMed 21187526
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.
PubMed 24326198
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.
PubMed 26762247
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.
PubMed 22381489
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.
PubMed 21745137
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.
PubMed 19232497
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.
PubMed 15334614
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.
PubMed 17361391

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
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Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
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Not yet recruiting
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All Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
ClinicalTrials.gov ID: NCT03202355
Acronym / sponsor ID: BX11
Conditions: Malocclusion
Keywords: Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor terminated due to clinical staffing changes and enrolment
Enrolment: 10 participants (actual)
Lead sponsor: Biolux Research Holdings, Inc.Industry (pharma, biotech, devices)
Study start: 20 Apr 2017 (actual)
Primary completion: 11 Mar 2019 (actual)
Study completion: 11 Mar 2019 (actual)
First posted: 28 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group 1 (Control)	Experimental	Device: Fixed Appliance Orthodontic TreatmentSubjects assigned to this group receive fixed appliance orthodontic treatment only
Group 2 (OP1)	Experimental	Device: Fixed Appliance Orthodontic Treatment, Device: OrthoPulse™Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.

Who may qualify

Ages: 11 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fixed Appliance Orthodontic TreatmentPatients 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.	Device	Group 1 (Control), Group 2 (OP1)
OrthoPulse™Patients carry out daily OrthoPulse™ treatments at home.	Device	Group 2 (OP1)

Primary outcome

Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
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.
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.

2 secondary outcomes

Effect of OrthoPulse PBM on external apical root resorption (EARR)
Time frame: 6 months after the start of orthodontic treatment
Risk of OrthoPulse PBM to the patient.
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

Results and safety

The study was stopped early (reason given: Sponsor terminated due to clinical staffing changes and enrolment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Background: PubMed 9155812Saito 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.
Background: PubMed 12539482Sun 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.
Background: PubMed 20159792Yamaguchi 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.
Background: PubMed 24470774Nimeri 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.
Background: PubMed 23990217Ekizer 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.
Background: PubMed 23139069Ekizer 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.
Background: PubMed 25017014El-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.
Background: PubMed 21187526Uysal 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.
Background: PubMed 24326198Kau 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.
Background: PubMed 26762247Shaughnessy 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.
Background: PubMed 22381489Doshi-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.
Background: PubMed 21745137Dias 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.
Individual participant dataSharing planned: No

Related trials for Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Brawn, DDS study director

Biolux Research Holdings, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fixed Appliance Orthodontic Treatment and OrthoPulse™ in people with Malocclusion, run by Biolux Research Holdings, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor terminated due to clinical staffing changes and enrolment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03202355, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.