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Study of the Use of Orthopulse Photobiomodulation

Biolux Technology GmbH · with medXteam GmbH · NCT05650359

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
42
US sites recruiting
1
Study start
October 13, 2022
Record last updated
August 7, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: OrthoPulse; No intervention

Conditions: Orthodontics

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Private Practice

    Chandler, AZ 85224

    Site contact: Todd Dickerson

Study contacts (from the official record)

  • Daniela Penn · 063219164033 · daniela.penn@medxteam.de
  • Mark N. Coreil, DDS · 337-412-2134 · mark@drcoreil.com
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Study of the Use of Orthopulse Photobiomodulation (NCT05650359) | Bored Studies