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

Orthodontic Tooth Movement Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04386278
Study type Interventional
Source Biolux Research Holdings, Inc.
Contact
Status Terminated
Phase N/A
Start date January 8, 2020
Completion date June 24, 2020
View Details
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