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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments. [Срок оценки: Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07639515 · IRB202600622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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