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

June 10, 2026 updated by: University of Florida

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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