OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)

RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical

This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.

A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.

All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.

Inclusion Criteria:

• Patient must be 19 years of age or older
• Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
• Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data

Exclusion Criteria:

• Patient is currently enrolled in another clinical study
• Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
• Periodontally involved teeth, acute oral infection or periodontal disease
• Patient has active/untreated caries
• Use of bisphosphonates at any time
• Use of drugs that may cause photosensitivity
• History of photosensitivity
• Epilepsy
• Pregnant or planning pregnancy during the study.
• Patient plans to relocate over the treatment period