OrthodonticsNCT05650359
Study of the Use of Orthopulse Photobiomodulation
A study testing OrthoPulse in people with Orthodontics, run by Biolux Technology GmbH at 1 site in United States.
Trial summary
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- OrthoPulse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Private Practice
Chandler, Arizona, 85224
Todd Dickerson
About this study
Official title: A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
Read the 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).
- Conditions
- Orthodontics
- Being tested
- OrthoPulse, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoPulseDevice
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 interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| OrthoPulse | Experimental | 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. Receives: Device: OrthoPulse |
| Control | Active comparator | 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this PMCF study is the rate of tooth alignment.
The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment.
Measured: 42 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start13 Oct 2022
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolux Technology GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- medXteam GmbH
- Responsible party
- Sponsor
- Investigators
- Todd Dickerson, Principal investigator, Private Practice 1200 W Warner Rd, Chandler, AZ 85224
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650359
- Sponsor's protocol ID
- OP_2021-02
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
- ClinicalTrials.gov ID
- NCT05650359
- Acronym / sponsor ID
- OP_2021-02
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Biolux Technology GmbHIndustry (pharma, biotech, devices)
- Collaborators
- medXteam GmbH
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
| Arm | Type | Receives |
|---|---|---|
| OrthoPulse | Experimental | Device: OrthoPulseThe 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. |
| Control | Active comparator | Other: No interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: at least 18 years
- Indication for an orthodontic treatment with fixed appliances
- Presence of a written declaration
- Permanent dentition
- Class I-III malocclusion
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthoPulseThe 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. | Device | OrthoPulse |
| No interventionNo intervention | Other | Control |
Primary outcome
The primary endpoint of this PMCF study is the rate of tooth alignment.
Time frame: 42 days after start of treatment
The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Dickerson principal investigator
Private Practice 1200 W Warner Rd, Chandler, AZ 85224
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoPulse in people with Orthodontics, run by Biolux Technology GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Penn (063219164033, daniela.penn@medxteam.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this PMCF study is the rate of tooth alignment. (time frame: 42 days after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.