Mixed Dentition Using Sequential Dental AlignersNCT07220317
This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using AirFlex Aligner, Sequential Dental Aligners.
A study testing Sequential Aligners in people with Mixed Dentition Using Sequential Dental Aligners, run by OrthoFX.
Trial summary
This study will examine shortened treatment wear time for patients with mixed dentition using sequential dental aligners. Using the existing AirFlex aligner design that patients with permanent dentition use, it may be possible to reduce the wear time and still provide dental realignment in an adequate treatment period… Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Mixed Dentition Using Sequential Dental Aligners
- What is being tested?
- Sequential Aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2026
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 7 to 21 years old
- Mixed dentition, as defined by the presence of at least one primary tooth present at the start of orthodontic treatment
- No untreated cavities
- Good Periodontal composition as determined by dental exam
Who cannot join
- Skeletal discrepancies requiring surgery
- Is currently undergoing dental/orthodontic work
- Has dental prosthesis/implants that will interfere with projected tooth movement
- Ongoing use of medication affecting tooth movement or bone formation (NSAIDS, Steroids, Bisphosphonates, Levothyroxine, Teriparatides, etc.)
- Is currently pregnant or plans to become pregnant during treatment
- Current smoker or tobacco use within 2 years
Show all 9Show fewer
- Presence of systemic diseases that could interfere with treatment
- Moderate or significant periodontal disease
- Any other physical exam finding that precludes participation
About this study
Official title: A Clinical Evaluation of Orthodontic Tooth Movements in Mixed Dentition
This study will examine shortened treatment wear time for patients with mixed dentition using sequential dental aligners. Using the existing AirFlex aligner design that patients with permanent dentition use, it may be possible to reduce the wear time and still provide dental realignment in an adequate treatment period for patients with mixed dentition. The Airflex aligner will be tested for a 9-12-hour patient wear time.
Read the detailed description
The primary intervention is the change in active wear time. In current practice, sequential aligners are prescribed to be worn approximately 20 to 22 hours per day. In this study, the prescribed wear time will be reduced to 9 - 12 hours per day.
This study is intended to demonstrate effectiveness of AirFlex aligners, which have a reduced wear time compared to traditional aligners, in mixed dentition subjects. The study will be conducted using AirFlex aligners, which are currently cleared for treatment of patients with permanent dentition.
- Being tested
- Sequential Aligners
- Keywords
- mixed dentition, dental aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential AlignersDevice
Treatment with sequential aligners in a shortened wear time with mixed dentition.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Short wear | Experimental | Short wear Receives: Device: Sequential Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will assess the tooth movements (torque, extrusion, rotation, translation, intrusions, and tipping), ensuring that final dentition is within 0.3 mm of the intended position.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Dentition Using Sequential Dental AlignersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoFX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220317
- Sponsor's protocol ID
- PRT-370
- Status last verified
- Oct 2025
- First submitted
- 9 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Orthodontic Tooth Movements in Mixed Dentition
- ClinicalTrials.gov ID
- NCT07220317
- Acronym / sponsor ID
- PRT-370
- Keywords
- mixed dentition, dental aligners
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- OrthoFXIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Oct 2025 (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 study will examine shortened treatment wear time for patients with mixed dentition using sequential dental aligners. Using the existing AirFlex aligner design that patients with permanent dentition use, it may be possible to reduce the wear time and still provide dental realignment in an adequate treatment period for patients with mixed dentition. The Airflex aligner will be tested for a 9-12-hour patient wear time.
Detailed description
The primary intervention is the change in active wear time. In current practice, sequential aligners are prescribed to be worn approximately 20 to 22 hours per day. In this study, the prescribed wear time will be reduced to 9 - 12 hours per day.
This study is intended to demonstrate effectiveness of AirFlex aligners, which have a reduced wear time compared to traditional aligners, in mixed dentition subjects. The study will be conducted using AirFlex aligners, which are currently cleared for treatment of patients with permanent dentition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Short wear | Experimental | Device: Sequential AlignersShort wear |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 7 to 21 years old
- Mixed dentition, as defined by the presence of at least one primary tooth present at the start of orthodontic treatment
- No untreated cavities
Key exclusion criteria (9 listed)
- Skeletal discrepancies requiring surgery
- Is currently undergoing dental/orthodontic work
- Has dental prosthesis/implants that will interfere with projected tooth movement
- Ongoing use of medication affecting tooth movement or bone formation (NSAIDS, Steroids, Bisphosphonates, Levothyroxine, Teriparatides, etc.)
- Is currently pregnant or plans to become pregnant during treatment
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 |
|---|---|---|
| Sequential AlignersTreatment with sequential aligners in a shortened wear time with mixed dentition. | Device | Experimental: Short wear |
Primary outcome
The primary endpoint will assess the tooth movements (torque, extrusion, rotation, translation, intrusions, and tipping), ensuring that final dentition is within 0.3 mm of the intended position.
Time frame: 16 weeks
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 23 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential Aligners in people with Mixed Dentition Using Sequential Dental Aligners, run by OrthoFX.
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 9 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: opening soon, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 primary endpoint will assess the tooth movements (torque, extrusion, rotation, translation, intrusions, and tipping), ensuring that final dentition is within 0.3 mm of the intended position. (time frame: 16 weeks). 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 Oct 2025.