Malocclusion
Conditions
Keywords
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Brief summary
The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.
Interventions
DEVICEFixed Appliance Orthodontic Treatment
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
DEVICEOrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.
Eligibility
Sex/Gender
ALL
Age
11 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Presence of permanent dentition * Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment * Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth * Class I or Class II malocclusion by ½ cusp or less * Non-extraction in both arches * Age 11-60 * Good oral hygiene * Non-smoker; non-use of chewing tobacco
Exclusion criteria
* Subject is currently enrolled in another clinical study * Subject decided on Invisalign rather than braces * Periodontally involved teeth * Use of bisphosphonates (osteoporosis drugs) during the study * Subject plans to relocate over the treatment period * Spaces between anterior teeth * Subject has dental implants or an implanted prosthesis * Sponsor employees, the Investigator and staff, as well as their immediate family members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients | From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment. | Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of OrthoPulse PBM on external apical root resorption (EARR) | 6 months after the start of orthodontic treatment | Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups. |
| Risk of OrthoPulse PBM to the patient. | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case | Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events. |
Countries
United States
Outcome results
None listed