Study of the Use of Orthopulse Photobiomodulation

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Biolux Technology GmbH
Study ID
NCT05650359
Status
Recruiting
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Conditions

  • Orthodontics

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • OrthoPulse — DEVICE
    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.
  • No intervention — OTHER
    No intervention

Study Details

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

Key Dates

Start date
Oct 13, 2022
Status verified
Aug 2024
Primary completion
May 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

The primary endpoint of this PMCF study is the rate of tooth alignment. [ Time Frame: 42 days after start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Private PracticeChandlerArizona85224
Todd Dickerson

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