Malocclusion
Conditions
Keywords
Malocclusion, Photobiomodulation, Biolux, OrthoPulse, Low-level laser therapy, Orthodontics
Brief summary
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.
Interventions
DEVICEOrthoPulse 2.0
Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
DEVICEOrthoPulse 2.1
Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
DEVICEInvisalign 3.5 Day Wear
Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.
DEVICEFixed Orthodontic Appliances (Braces)
Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feedback on general experience | Through Study Completion, approx. 2 years | Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system. |
| Feedback on clinical performance | Through Study Completion, approx. 2 years | Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system. |
| Adverse events | Through Study Completion, approx. 2 years | Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1 |
Countries
Canada, United States
Outcome results
None listed