Study of the Use of Orthopulse Photobiomodulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OrthoPulse, No intervention.
- Who it may be relevant to
- Registry conditions: Orthodontics. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
Overview
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
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).
Interventions
- 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 devi - Other No intervention
No intervention
Primary outcome measures
- The primary endpoint of this PMCF study is the rate of tooth alignment. [Time frame: 42 days after start of treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Private Practice — Chandler
Identifiers
NCT: NCT05650359 · OP_2021-02