MalocclusionBX8RNNCT02267811

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

A study testing Orthodontic Treatment and OrthoPulse™ in people with Malocclusion, run by Biolux Research Holdings, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 11 to 60 years
Conditions the study is for: Malocclusion
What is being tested?: Orthodontic Treatment and OrthoPulse™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stone Oak Orthodontics
San Antonio, Texas, 78232

Other trials in United States

About this study

Official title: The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances

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.

Read the detailed description

The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Conditions: Malocclusion
Being tested: Orthodontic Treatment, OrthoPulse™
Keywords: 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.

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.
OrthoPulse™Device
Participants carry out daily OrthoPulse™ treatments at home.

Study groups in NCT02267811
Study group	Role	What they receive
Fixed Orthodontic Treatment with OrthoPulse™	Experimental	Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. Receives: Other: Orthodontic Treatment; Device: OrthoPulse™
Fixed Orthodontic Treatment	Experimental	Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment. Receives: Other: Orthodontic Treatment

What is being measured

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

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.
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.

Secondary outcomes (2)

Safety Evidence of OrthoPulse™ Use
The number of significant adverse events reported from time of participant enrolment to study completion for all study participants
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.
Degree of External Apical Root Resorption (EARR)
The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters.
A positive number under the measure of dispersion signifies root resorption.
Measured: Assessed at six (6) months or later after starting treatment, up to two (2) years.

Timeline

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

Oct 2013Jun 2016

First posted20 Oct 2014 (estimated)
Study startOct 2013
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (34)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
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02267811
Sponsor's protocol ID: BX8RN
Acronym: BX8RN
Status last verified: May 2019
First submitted: 10 Oct 2014
Last updated: 21 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003.
PubMed 16473715
Kawakami M, Takano-Yamamoto T. Local injection of 1,25-dihydroxyvitamin D3 enhanced bone formation for tooth stabilization after experimental tooth movement in rats. J Bone Miner Metab. 2004;22(6):541-6. doi: 10.1007/s00774-004-0521-3.
PubMed 15490263
Yamasaki K, Shibata Y, Imai S, Tani Y, Shibasaki Y, Fukuhara T. Clinical application of prostaglandin E1 (PGE1) upon orthodontic tooth movement. Am J Orthod. 1984 Jun;85(6):508-18. doi: 10.1016/0002-9416(84)90091-5.
PubMed 6587784
Seifi M, Eslami B, Saffar AS. The effect of prostaglandin E2 and calcium gluconate on orthodontic tooth movement and root resorption in rats. Eur J Orthod. 2003 Apr;25(2):199-204. doi: 10.1093/ejo/25.2.199.
PubMed 12737218
Hashimoto F, Kobayashi Y, Mataki S, Kobayashi K, Kato Y, Sakai H. Administration of osteocalcin accelerates orthodontic tooth movement induced by a closed coil spring in rats. Eur J Orthod. 2001 Oct;23(5):535-45. doi: 10.1093/ejo/23.5.535.
PubMed 11668873
Madan MS, Liu ZJ, Gu GM, King GJ. Effects of human relaxin on orthodontic tooth movement and periodontal ligaments in rats. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):8.e1-10. doi: 10.1016/j.ajodo.2006.06.014.
PubMed 17208099
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.
PubMed 8060014
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.
PubMed 6243447
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.
PubMed 18405822
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.
PubMed 16648212
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.
PubMed 1059332
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
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.
PubMed 21254890
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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Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances
ClinicalTrials.gov ID: NCT02267811
Acronym / sponsor ID: BX8RN / BX8RN
Conditions: Malocclusion
Keywords: Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Biolux Research Holdings, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 20 Oct 2014 (estimated)
Results: Posted 21 May 2019

Clinical summary

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

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.

Detailed description

The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Study design

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

Arm	Type	Receives
Fixed Orthodontic Treatment with OrthoPulse™	Experimental	Other: Orthodontic Treatment, Device: OrthoPulse™Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Fixed Orthodontic Treatment	Experimental	Other: Orthodontic TreatmentSubjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.

Who may qualify

Ages: 11 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

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
Orthodontic TreatmentPatients 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.	Other	Fixed Orthodontic Treatment, Fixed Orthodontic Treatment with OrthoPulse™
OrthoPulse™Participants carry out daily OrthoPulse™ treatments at home.	Device	Fixed Orthodontic Treatment with OrthoPulse™

Primary outcome

Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
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.
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.

2 secondary outcomes

Safety Evidence of OrthoPulse™ Use
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.
Degree of External Apical Root Resorption (EARR)
Time frame: Assessed at six (6) months or later after starting treatment, up to two (2) years.

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)	16	15
BX8RN: Orthodontic Treatment (Control)	17	15

Primary outcome: Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment

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.. Mean (Standard Deviation). Unit: millimeters per week

Measure	BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) n = 15	BX8RN: Orthodontic Treatment (Control) n = 15
Value	1.09 (.68)	.39 (.14)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at all visits from the time of participant enrolment through the study final visit, two (2) years or less.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Orthodontic Treatment With OrthoPulse™ (Treatment)	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Fixed Orthodontic Treatment (Control)	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16473715Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003.
Background: PubMed 15490263Kawakami M, Takano-Yamamoto T. Local injection of 1,25-dihydroxyvitamin D3 enhanced bone formation for tooth stabilization after experimental tooth movement in rats. J Bone Miner Metab. 2004;22(6):541-6. doi: 10.1007/s00774-004-0521-3.
Background: PubMed 6587784Yamasaki K, Shibata Y, Imai S, Tani Y, Shibasaki Y, Fukuhara T. Clinical application of prostaglandin E1 (PGE1) upon orthodontic tooth movement. Am J Orthod. 1984 Jun;85(6):508-18. doi: 10.1016/0002-9416(84)90091-5.
Background: PubMed 12737218Seifi M, Eslami B, Saffar AS. The effect of prostaglandin E2 and calcium gluconate on orthodontic tooth movement and root resorption in rats. Eur J Orthod. 2003 Apr;25(2):199-204. doi: 10.1093/ejo/25.2.199.
Background: PubMed 11668873Hashimoto F, Kobayashi Y, Mataki S, Kobayashi K, Kato Y, Sakai H. Administration of osteocalcin accelerates orthodontic tooth movement induced by a closed coil spring in rats. Eur J Orthod. 2001 Oct;23(5):535-45. doi: 10.1093/ejo/23.5.535.
Background: PubMed 17208099Madan MS, Liu ZJ, Gu GM, King GJ. Effects of human relaxin on orthodontic tooth movement and periodontal ligaments in rats. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):8.e1-10. doi: 10.1016/j.ajodo.2006.06.014.
Background: PubMed 8060014Frost 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.
Background: PubMed 6243447Davidovitch 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.
Background: PubMed 18405822Nishimura 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.
Background: PubMed 16648212Bernabe 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.
Background: PubMed 1059332Little 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.
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.

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
Malocclusions, Canine Retraction
Not yet recruiting
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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

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

Questions about this trial

What is this clinical trial studying?

A study testing Orthodontic Treatment and OrthoPulse™ in people with Malocclusion, run by Biolux Research Holdings, Inc. at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment (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.). 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 NCT02267811, which also lists 34 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 21 May 2019.