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NCT Number: NCT07639515

Randomized In-Vivo Comparison of 3D-Printed and Thermoformed Clear Aligners: A Multi-Subject, Time-Dependent Analysis of Adaptation and Trueness

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.

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Key information

Conditions

Adaptation of Different Types of Clear Aligners

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Device: Invisalign Passive Clear Aligner

Device

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.

Spark Passive aligners

Device

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.

Zendura passive aligner

Device

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.

Graphy passive aligner

Device

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.

Luxcreo passive aligner

Device

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.

Primary outcomes

  1. Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

3D-Printed and Thermoformed Clear Aligners: Analysis of Adaptation and Trueness.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.