Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2022-10-13
2028-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No intervention
No intervention
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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medXteam GmbH
OTHER
Biolux Technology GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Dickerson
Role: PRINCIPAL_INVESTIGATOR
Private Practice 1200 W Warner Rd, Chandler, AZ 85224
Locations
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Private Practice
Chandler, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Todd Dickerson
Role: primary
Other Identifiers
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OP_2021-02
Identifier Type: -
Identifier Source: org_study_id
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