Malocclusion
Conditions
Keywords
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™, Invisalign
Brief summary
The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.
Interventions
DEVICEInvisalign (7 day)
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.
DEVICEInvisalign (5 day)
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.
DEVICEOrthoPulse
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
DEVICEInvisalign (3.5 day)
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Invisalign Full Treatment product only * Have a permanent dentition * 18 years-old * Angle Class I or ½ cusp Class II molar and canine relationship * Moderate to mild crowding in at least one arch
Exclusion criteria
* Subjects who do not fulfill all inclusion criteria requirements * Craniofacial anomaly present * Past or present signs and symptoms of periodontal disease * A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement * Previous orthodontic or orthopedic relapse within 1 year * History of trauma, bruxism, or parafunction * Skeletal jaw discrepancy * Use of osteoporosis drugs * Initial use of auxiliary mechanics such as elastics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of tooth movement | From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years | Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of treatment time | From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years | Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time. |
| Effect of photobiomodulation on external apical root resorption | From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years | Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment, |
Countries
United States
Outcome results
None listed