This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using Air… (NCT07220317) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using AirFlex Aligner, Sequential Dental Aligners.
45 participantsStarted 2026-01
Plain-language 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 for patients with mixed dentition. The Airflex aligner will be tested for a 9-12-hour patient wear time.
Who can participate
Age range
7 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Presence of systemic diseases that could interfere with treatment
* Moderate or significant periodontal disease
* Any other physical exam finding that precludes participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.