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Purpose

This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OrthoPulse 		The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment.
  • Device: OrthoPulse
    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.
Active Comparator
Control 		The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment.
  • Other: No intervention
    No intervention

Recruiting Locations

Private Practice
Chandler, Arizona 85224
Contact:
Todd Dickerson

More Details

Status
Recruiting
Sponsor
Biolux Technology GmbH

Study Contact

Daniela Penn
063219164033
daniela.penn@medxteam.de

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.