The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Invisalign (7 day)
* Device: Invisalign (5 day)
* Device: OrthoPulse
* Device: Invisalign (3.5 day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Skeletal jaw discrepancy Use of osteoporosis drugs Initial use of auxiliary mechanics such as elastics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I7: Control<br>Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days. | Device: Invisalign (7 day)<br>* 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.<br>|
| Experimental: OP7: OrthoPulse Treatment<br>Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days. | Device: Invisalign (7 day)<br>* 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.<br>Device: OrthoPulse<br>* Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.<br>|
| Experimental: OP5: OrthoPulse Treatment<br>Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days. | Device: Invisalign (5 day)<br>* 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.<br>Device: OrthoPulse<br>* Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.<br>|
| Experimental: OP3.5: OrthoPulse Treatment<br>Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days. | Device: OrthoPulse<br>* Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.<br>Device: Invisalign (3.5 day)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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, | From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™, Invisalign