The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement (BX8RN)

Biolux Research

Status: Completed

Conditions: Malocclusion

Treatments: Device: OrthoPulse™; Other: Orthodontic Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267811

BX8RN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 11 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Fixed Orthodontic Treatment with OrthoPulse™

Experimental group

Description:

Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.

Treatment:

Device: OrthoPulse™

Other: Orthodontic Treatment

Fixed Orthodontic Treatment

Experimental group

Description:

Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.

Treatment:

Other: Orthodontic Treatment