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Not yet recruiting NCT07639515

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

No phase Interventional Adaptation of Different Types of Clear Aligners

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Device: Invisalign Passive Clear Aligner, Spark Passive aligners, Zendura passive aligner, Graphy passive aligner.
Who it may be relevant to
Registry conditions: Adaptation of Different Types of Clear Aligners. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • 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).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07639515 · IRB202600622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗