Study of the Use of Orthopulse Photobiomodulation

Study Overview
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Brief Summary
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This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

Detailed Description
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The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).

Official Title
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A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances

Conditions
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Orthodontics

Intervention / Treatment
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* Device: OrthoPulse
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: at least 18 years Indication for an orthodontic treatment with fixed appliances Presence of a written declaration Permanent dentition Class I-III malocclusion Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint) Exclusion Criteria: Simultaneous participation in another clinical investigation or study Prior participation in this study Persons who have been placed in an institution as a result of an administrative or judicial order Persons who are dependent on the sponsor, Investigator or the investigation site Anterior cross bite Spaces between anterior teeth Extractions or missing permanent teeth (except for third molars) No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase Acute oral infection or periodontal disease Active caries Pregnant patients or patients planning to become pregnant

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
Interventional Model Description: This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoPulse<br>The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment. | Device: OrthoPulse<br>* The OrthoPulse device is intended to accelerate orthodontic movement of teeth and reduce the overall treatment time for the patient. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners. OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses safe, high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. OrthoPulse is an established device that uses low levels of light energy to stimulate the bone surrounding the roots of teeth and facilitate tooth movement which may reduce treatment time for braces or clear aligners.<br>|
| Active Comparator: Control<br>The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this PMCF study is the rate of tooth alignment. | The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment. | 42 days after start of treatment |