Orthodontic Tooth MovementNCT04386278
OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Orthodontic Tooth Movement, run by Biolux Research Holdings, Inc. at 1 site in Canada.
Trial summary
This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Intervention 1, Intervention 2 and Intervention 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2020to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be 19 years of age or older
- Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
- Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data
Who cannot join
- Patient is currently enrolled in another clinical study
- Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
- Periodontally involved teeth, acute oral infection or periodontal disease
- Patient has active/untreated caries
- Use of bisphosphonates at any time
- Use of drugs that may cause photosensitivity
Show all 10Show fewer
- History of photosensitivity
- Epilepsy
- Pregnant or planning pregnancy during the study.
- Patient plans to relocate over the treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.
A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.
All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Intervention 1, Intervention 2, Intervention 3, Intervention 4, Intervention 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Device
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 2Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 3Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
Intervention 4Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
Intervention 5Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 6Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Intervention 7Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 8Device
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute Receives: Device: Intervention 1 |
| Intervention 2 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute Receives: Device: Intervention 2 |
| Intervention 3 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes Receives: Device: Intervention 3 |
| Intervention 4 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes Receives: Device: Intervention 4 |
| Intervention 5 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute Receives: Device: Intervention 5 |
| Intervention 6 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes Receives: Device: Intervention 6 |
| Intervention 7 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute Receives: Device: Intervention 7 |
| Intervention 8 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes Receives: Device: Intervention 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of orthodontic tooth movement
The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week).
Measured: 36 days (±12 days) from T0 visit
Secondary outcomes (3)
Peak Pain: Questionnaire
Assess peak pain experienced over first seven (7) days of treatment during intrusion using a questions similar in nature to a Visual Analog Scale (subject to complete pain questionnaire).
Measured: 7 Days
Root Resorption
Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3
Measured: 36 days (±12 days) from T0 visit
Initial Safety of Device
Confirmation of safety through collection of adverse events
Measured: From enrolment to study completion, anticipated six (6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start8 Jan 2020
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Why it stopped: Study stopped because slow enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each group in this study includes a different device iteration that is being investigated in parallel.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolux Research Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386278
- Sponsor's protocol ID
- RI.2
- Status last verified
- Nov 2020
- First submitted
- 8 Apr 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
- ClinicalTrials.gov ID
- NCT04386278
- Acronym / sponsor ID
- RI.2
- Conditions
- Orthodontic Tooth Movement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped because slow enrolment.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Biolux Research Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 13 May 2020 (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 is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.
A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.
All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Each group in this study includes a different device iteration that is being investigated in parallel.
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Device: Intervention 1Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute |
| Intervention 2 | Experimental | Device: Intervention 2Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute |
| Intervention 3 | Experimental | Device: Intervention 3Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes |
| Intervention 4 | Experimental | Device: Intervention 4Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes |
| Intervention 5 | Experimental | Device: Intervention 5Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
| Intervention 6 | Experimental | Device: Intervention 6Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes |
| Intervention 7 | Experimental | Device: Intervention 7Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
| Intervention 8 | Experimental | Device: Intervention 8Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be 19 years of age or older
- Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
- Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data
Key exclusion criteria (10 listed)
- Patient is currently enrolled in another clinical study
- Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
- Periodontally involved teeth, acute oral infection or periodontal disease
- Patient has active/untreated caries
- Use of bisphosphonates at any time
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 |
|---|---|---|
| Intervention 1Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute | Device | Intervention 1 |
| Intervention 2Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute | Device | Intervention 2 |
| Intervention 3Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes | Device | Intervention 3 |
| Intervention 4Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes | Device | Intervention 4 |
| Intervention 5Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute | Device | Intervention 5 |
| Intervention 6Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes | Device | Intervention 6 |
| Intervention 7Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute | Device | Intervention 7 |
| Intervention 8Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes | Device | Intervention 8 |
Primary outcome
The rate of orthodontic tooth movement
Time frame: 36 days (±12 days) from T0 visit
The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week).
3 secondary outcomes
Peak Pain: Questionnaire
Time frame: 7 Days
Root Resorption
Time frame: 36 days (±12 days) from T0 visit
Initial Safety of Device
Time frame: From enrolment to study completion, anticipated six (6) months
Results and safety
The study was stopped early (reason given: Study stopped because slow enrolment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Orthodontic Tooth Movement, run by Biolux Research Holdings, Inc. at 1 site in Canada.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 23 Nov 2020. 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 Canada. 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?
The study was stopped early (reason given: Study stopped because slow enrolment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of orthodontic tooth movement (time frame: 36 days (±12 days) from T0 visit). 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 23 Nov 2020.