Recruiting

Orthopulse

Sponsor:

Biolux Technology GmbH

Code:

NCT05650359

Conditions

Orthodontics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

OrthoPulse

No intervention

Study Details

Brief summary:

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

Conditions

Orthodontics

Study ID

NCT05650359

Start date

Oct 13, 2022

Status verified date

Aug, 2024

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

No intervention

No intervention

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 and Locations

Central contacts

Daniela Penn

063219164033daniela.penn@medxteam.de

Mark N. Coreil, DDS

337-412-2134mark@drcoreil.com

Locations

Private Practice

Recruiting

Chandler, Arizona, United States, 85224

More Information

Sponsor

Biolux Technology GmbH

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biolux Technology GmbH on 2024-08-07.