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Идёт набор NCT06273449

A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures

Без фазы С лечением Partial-edentulism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group 3 - 3D Printed Removable Partial Denture, Group 2 - 3D Printed Removable Partial Denture.
Кому может быть актуально
Состояния в реестре: Partial-edentulism. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.

Подробное описание

Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.

Towards this goal, we have developed an intelligent RPD design software prototype, SmartRPD, to generate RPD metal framework design using digital scans from patients. SmartRPD processes patient-specific scanned geometry instantly, provide diagnosis analysis and generate the first draft of metal framework design automatically, powered by a teeth geometry segmentation system, knowledge-based design algorithm and 3D geometry engines. Dentists make the final clinical changes and confirmation before sending the 3D digital files for 3D printing. Thereafter, an altered digital scan technique is used to register a precise digital scan of soft tissues under functioning, using the metal framework as a loading impression tray and digitally align to the initial oral scan. This resulted modified master scan file leads to a more accurate setting for the denture base in the subsequent procedures.

Вмешательства

  • Устройство Group 3 - 3D Printed Removable Partial Denture
    Teeth Profile Capture Method: Intraoral scan RPD Design Method: Based on intraoral scan, using design software RPD Fabrication Method: Additive manufacturing
  • Устройство Group 2 - 3D Printed Removable Partial Denture
    Teeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing

Первичные конечные точки

  • Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows [Срок оценки: Assessed at the end of the study period, up to 14 months]
  • Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows [Срок оценки: From date of randomization during first visit till 3rd follow up visit, assessed up to 14 months]
  • Comparison of Fabrication Cost and Time Across Three Workflows [Срок оценки: Assessed at the end of the study period, up to 14 months]

Критерии участия

Критерии включения

  • above the age of 21 years' old
  • medically fit
  • with prior denture experience
  • either maxillary or mandible partial dentate
  • partial edentulism with stable occlusion

Критерии исключения

  • History of maladaptation to denture use
  • With maxillofacial or mandible bone defect(s)
  • Known allergic reaction to cobalt chromium metal

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Сингапур · 1 центр
  • National Dental Centre Singapore — Singapore

Идентификаторы

NCT: NCT06273449 · 385/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗