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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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