Status:
NOT_YET_RECRUITING
This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using AirFlex Aligner, Sequential Dental Aligners.
Lead Sponsor:
OrthoFX
Conditions:
Mixed Dentition Using Sequential Dental Aligners
Eligibility:
All Genders
7-21 years
Phase:
NA
Brief 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 dentiti...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07220317
Start Date
January 1 2026
End Date
December 1 2026
Last Update
October 23 2025
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