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

NCT07639515 | Not Yet Recruiting

• 1 other identifier: IRB202600622
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adaptation of Different Types of Clear Aligners

Outcome Measures

Primary Outcomes (1)

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

  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

  Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).

Study Arms (2)

Attachment group

EXPERIMENTAL

Device: Device: Invisalign Passive Clear Aligner; Device: Spark Passive aligners; Device: Zendura passive aligner; Device: Graphy passive aligner; Device: Luxcreo passive aligner

No attachment group

NO INTERVENTION

Interventions

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.

Attachment group

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.

Attachment group

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.

Attachment group

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.

Attachment group

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.

Attachment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): February 21, 2028
• Study Completion (Estimated): April 6, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06