Adaptation of Different Types of Clear Aligners
Conditions
Brief summary
This prospective clinical study aims to evaluate and compare the in vivo adaptation and trueness of clear aligners fabricated using thermoforming and direct three-dimensional (3D) printing technologies.
Interventions
DEVICEDevice: Invisalign Passive Clear Aligner
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
DEVICESpark Passive aligners
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
DEVICEZendura passive aligner
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
DEVICEGraphy passive aligner
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
DEVICELuxcreo passive aligner
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers aged 18 years or older. * Good general and oral health. * Dentition adequate to support passive upper clear aligner wear, as determined by the investigator. * Willing and able to attend all study visits over the 4-6 month study period. * Willing and able to comply with aligner wear and all study procedures. * Able to provide written informed consent and HIPAA authorization.
Exclusion criteria
* Active dental or periodontal disease, or any oral condition that could interfere with study procedures. * Need for active orthodontic treatment or other dental procedures during the study period. * Poor oral hygiene or failure to follow study instructions at the screening visit. * Medical or systemic conditions, or use of medications, that could compromise participation or study outcomes. * Concurrent participation in another interventional research study. * Pregnancy or planned pregnancy during the study period (if applicable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments. | Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days). | Mean 3D distance (millimeters) between the inner surface of the passive clear aligner and the corresponding tooth surface, computed from superimposed digital intraoral scans at baseline, 24 hours, 7 days, and 14 days of wear for each aligner system, comparing attachment and non-attachment groups |
Outcome results
None listed