Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers

Обзор

This study aims to compare two types of orthodontic retainers used after active treatment to maintain teeth position. The retainers are fabricated using either direct 3D-printing or thermoforming methods. The study will evaluate which method provides better dimensional accuracy (fit) and color stability over time. Adult patients who have completed their orthodontic treatment will be randomly assigned to one of three groups, each receiving a different type of retainer. The research is conducted at the Faculty of Dental Medicine, Al-Azhar University - Assiut Branch. The goal is to help orthodontists select the most reliable and durable type of retainer for long-term use.

Подробное описание

This randomized clinical and laboratory study investigates the dimensional accuracy and color stability of orthodontic retainers fabricated using two different techniques: direct 3D printing and thermoforming. Patients who have completed active orthodontic treatment will be recruited and assigned to three groups. Group T1 will receive 3D-printed retainers, Group T2 will receive single-layer thermoformed retainers, and Group T3 will receive multi-layer thermoformed retainers…

Вмешательства

• Устройство Direct 3D-Printed Retainer
  Orthodontic retainers fabricated using direct 3D printing technology from digital STL models. The retainers are printed with biocompatible clear resin using an additive manufacturing process.
• Устройство Single-Layer Thermoformed Retainer
  Clear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine.
• Устройство Multi-Layer Thermoformed Retainer
  Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy.

Первичные конечные точки

• Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month [Срок оценки: 1 month after retainer delivery]

Вторичные конечные точки (1)

• Color Change (ΔE) of Retainers Measured by Spectrophotometer Based on CIE L*a*b* System After 1 Month [Срок оценки: 1 month after retainer delivery]

Критерии участия

Критерии включения

• Patients who have completed their active orthodontic treatment.
• Adults aged 18 years and above.
• Cooperative individuals willing to participate.
• Patients with good oral hygiene and general health.
• No systemic diseases that may affect treatment outcomes.

Критерии исключения

• Smokers.
• Patients with a history of poor compliance with previous orthodontic treatment.
• Patients with parafunctional oral habits (e.g., bruxism).
• Patients undergoing retreatment due to relapse.

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dental Medicine, Al-Azhar University - Assiut Branch — Asyut

Идентификаторы

NCT: NCT07053410 · Orthodontic retainers

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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