MalocclusionNCT02954133
The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
A study testing Invisalign (7 day), Invisalign (5 day) and OrthoPulse in people with Malocclusion, run by Biolux Research Holdings, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Invisalign (7 day), Invisalign (5 day) and OrthoPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2016to Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Invisalign "Full Treatment" product only
- Have a permanent dentition
- 18 years-old
- Angle Class I or ½ cusp Class II molar and canine relationship
- Moderate to mild crowding in at least one arch
Who cannot join
- Subjects who do not fulfill all inclusion criteria requirements
- 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
Show all 9Show fewer
- Skeletal jaw discrepancy
- Use of osteoporosis drugs
- Initial use of auxiliary mechanics such as elastics
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dickerson Orthodontics
Chandler, Arizona, 85224
Chenin Orthodontics
Henderson, Nevada, 89052
Kottemann Orthodontics
Maple Grove, Minnesota, 55369
Orthodontic Associates
Oklahoma City, Oklahoma, 73120
About this study
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.
- Conditions
- Malocclusion
- Being tested
- Invisalign (7 day), Invisalign (5 day), OrthoPulse, Invisalign (3.5 day)
- Keywords
- Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™, Invisalign
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
OrthoPulseDevice
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
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.
| Study group | Role | What they receive |
|---|---|---|
| I7: Control | Experimental | Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days. Receives: Device: Invisalign (7 day) |
| OP7: OrthoPulse Treatment | Experimental | Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days. Receives: 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. Receives: 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. Receives: Device: OrthoPulse; Device: Invisalign (3.5 day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time.
Measured: 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
Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment,
Measured: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolux Research Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Brawn, DDS, Study director, Biolux Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954133
- Sponsor's protocol ID
- BX9
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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 12539482Saito 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 9155812Yamaguchi 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 20159792Nimeri 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 24470774Ekizer 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 23990217Ekizer 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 23139069El-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 25017014Uysal 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 21187526Kau 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 24326198Shaughnessy 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 26762247Doshi-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 22381489Dias 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 21745137Silveira 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 19232497Cruz 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 15334614Youssef 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
- ClinicalTrials.gov ID
- NCT02954133
- Acronym / sponsor ID
- BX9
- Conditions
- Malocclusion
- Keywords
- Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™, Invisalign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Biolux Research Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I7: Control | Experimental | Device: Invisalign (7 day)Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days. |
| OP7: OrthoPulse Treatment | Experimental | Device: Invisalign (7 day), Device: OrthoPulseSubjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days. |
| OP5: OrthoPulse Treatment | Experimental | Device: Invisalign (5 day), Device: OrthoPulseSubjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days. |
| OP3.5: OrthoPulse Treatment | Experimental | Device: OrthoPulse, Device: Invisalign (3.5 day)Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Invisalign "Full Treatment" product only
- Have a permanent dentition
- Angle Class I or ½ cusp Class II molar and canine relationship
- Moderate to mild crowding in at least one arch
Key exclusion criteria (9 listed)
- Subjects who do not fulfill all inclusion criteria requirements
- 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
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 |
|---|---|---|
| Invisalign (7 day)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. | Device | I7: Control, OP7: OrthoPulse Treatment |
| Invisalign (5 day)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. | Device | OP5: OrthoPulse Treatment |
| OrthoPulseDaily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home. | Device | OP3.5: OrthoPulse Treatment, OP5: OrthoPulse Treatment, OP7: OrthoPulse Treatment |
| Invisalign (3.5 day)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. | Device | OP3.5: OrthoPulse Treatment |
Primary outcome
Rate of tooth movement
Time frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years
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.
2 secondary outcomes
Length of treatment time
Time frame: 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
Time frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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 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 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.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign (7 day), Invisalign (5 day) and OrthoPulse in people with Malocclusion, run by Biolux Research Holdings, Inc. at 4 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 (time frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years). 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 NCT02954133, which also lists 19 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 15 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.