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

3D-Printed and Thermoformed Clear Aligners: 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adaptation of Different Types of Clear Aligners
• Intervention / Treatment: Device: Device: Invisalign Passive Clear Aligner; Device: Spark Passive aligners; Device: Zendura passive aligner; Device: Graphy passive aligner; Device: Luxcreo passive aligner

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attachment group	Device: Device: 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.; Device: Spark 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.; Device: Zendura 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.; Device: Graphy 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.; Device: Luxcreo 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.
No Intervention: No attachment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): February 21, 2028
• Study Completion (Estimated): April 6, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB202600622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No