Mixed Dentition Using Sequential Dental Aligners
Conditions
Keywords
mixed dentition, dental aligners
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 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.
Interventions
DEVICESequential Aligners
Treatment with sequential aligners in a shortened wear time with mixed dentition.
Sponsors
OrthoFX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 16 weeks |
Outcome results
None listed