Organization's Unique Protocol ID

Официальное название

Adaptation and Patient Satisfaction of 3-D Printed Versus Conventional Acrylic Overdentures in Patients With Ectodermal Dysplasia: A Crossover Prospective Clinical Trial

Обзор

Ectodermal dysplasia is a rare inherited condition that affects structures derived from the ectoderm, including teeth, skin, hair, and sweat glands. Dental findings are often severe and include missing or malformed teeth and poorly developed jaw ridges. These abnormalities can significantly affect chewing, speech, facial appearance, and quality of life, especially in children and young adults. Removable dentures, particularly overdentures when some teeth are present, are commonly used to restore function and appearance in these patients because they are conservative and cost-effective. However, conventional acrylic dentures may show dimensional changes during processing, which can lead to poor denture fit, reduced retention, and lower patient satisfaction. Three-dimensional (3-D) printed dentures are a newer digital fabrication method that may reduce material shrinkage and improve denture adaptation. Despite these potential advantages, clinical evidence comparing 3-D printed and conventional overdentures in patients with ectodermal dysplasia remains limited, highlighting the need for well-designed clinical studies. The purpose of this study is to compare patient satisfaction and denture base adaptation between 3-D printed maxillary overdentures and conventional acrylic maxillary overdentures in patients with ectodermal dysplasia.

Подробное описание

Ectodermal dysplasia patients suffer from partial anodontia, the reduced number of teeth leads to decreased ridge development and reduced surface area of denture which negatively affects the denture adaptation. Conventionally constructed dentures are well accepted but have high polymerization shrinkage which affects denture adaptation. 3D printed dentures offer less polymerization shrinkage when compared to conventional dentures. Clinical studies that investigated digitally manufactured, especially 3D printed, dentures in ectodermal dysplasia patients and their impact on patient satisfaction and denture adaptation are very scarce in dental literature.

Вмешательства

• Устройство 3-D printed overdenture
  Overdenture is constructed using 3 -D printing technology not conventional processing of acrylic resin
• Устройство Conventional overdenture
  overdentures will be constructed using Conventional acrylic processing method

Первичные конечные точки

• Patient satisfaction [Срок оценки: after 1 week and after 3 months after delivery of each denture]

Вторичные конечные точки (1)

• Denture adaptation [Срок оценки: on delivery day and after 3 months of each denture delivery]

Критерии участия

Критерии включения

• Age must range from 10-35 years.
• Must have a few remaining teeth in the maxilla.
• Must will to attend all follow-ups.

Критерии исключения

• Extreme anatomical limitations such as a large torus that requires surgical excision.
• Allergy to dentures made of resins.
• Pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.

4\. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Cairo University — Cairo

Идентификаторы

NCT: NCT07468019 · ED-OD-3DPvsCA-CO-CT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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