OrthoPulse 2.0 and 2.1 Feasibility Evaluation (BX13)

Biolux Research

Status: Unknown

Conditions: Malocclusion

Treatments: Device: Invisalign 3.5 Day Wear; Device: OrthoPulse 2.0; Device: OrthoPulse 2.1; Device: Fixed Orthodontic Appliances (Braces)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03683017

BX13

Details and patient eligibility

About

OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.

Enrollment: 35 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written Informed Consent must be obtained before any assessment is performed
• Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
• Presence of permanent dentition
• Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
• Good oral hygiene
• Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
• Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data

Exclusion criteria

• Patient is currently enrolled in another clinical study
• Periodontally involved teeth, acute oral infection or periodontal disease
• Use of bisphosphonates (osteoporosis drugs) during the study
• Use of drugs that may cause photosensitivity
• History of photosensitivity
• History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
• Epilepsy
• Patient plans to relocate over the treatment period
• Smoker or use of any tobacco containing products per the discretion of the PI

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 3 patient groups

I-OP2.0

Experimental group

Description:

Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.

Treatment:

Device: OrthoPulse 2.0

Device: Invisalign 3.5 Day Wear

I-OP2.1

Experimental group

Description:

Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.

Treatment:

Device: OrthoPulse 2.1

Device: Invisalign 3.5 Day Wear

F-OP2.0

Experimental group

Description:

Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.

Treatment:

Device: OrthoPulse 2.0

Device: Fixed Orthodontic Appliances (Braces)