Orthodontics
Conditions
Brief summary
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
Detailed description
The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).
Interventions
DEVICEOrthoPulse
The OrthoPulse device is intended to accelerate orthodontic movement of teeth and reduce the overall treatment time for the patient. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners. OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses safe, high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. OrthoPulse is an established device that uses low levels of light energy to stimulate the bone surrounding the roots of teeth and facilitate tooth movement which may reduce treatment time for braces or clear aligners.
OTHERNo intervention
No intervention
Sponsors
medXteam GmbH
Biolux Technology GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Intervention model description
This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age: at least 18 years * Indication for an orthodontic treatment with fixed appliances * Presence of a written declaration * Permanent dentition * Class I-III malocclusion * Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)
Exclusion criteria
* Simultaneous participation in another clinical investigation or study * Prior participation in this study * Persons who have been placed in an institution as a result of an administrative or judicial order * Persons who are dependent on the sponsor, Investigator or the investigation site * Anterior cross bite * Spaces between anterior teeth * Extractions or missing permanent teeth (except for third molars) * No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase * Acute oral infection or periodontal disease * Active caries * Pregnant patients or patients planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of this PMCF study is the rate of tooth alignment. | 42 days after start of treatment | The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment. |
Countries
United States
Contacts
Primary ContactDaniela Penn
Backup ContactMark N. Coreil, DDS
Outcome results
None listed