"Augmented Reality-Assisted Miniscrew Placement in Orthodontics: A Clinical Trial"

Официальное название

"A Clinical Trial Investigating the Accuracy of Augmented Reality-Guided Miniscrew Placement in Orthodontics"

Обзор

This study aims to evaluate the effectiveness and accuracy of using Augmented Reality (AR) technology in the placement of mini-screws (Temporary Anchorage Devices) during orthodontic treatment. By combining CBCT images with digital dental scans and visualizing them using AR, clinicians can place mini-screws more precisely. The study is a pilot clinical trial involving patients at the Faculty of Dentistry, Al-Azhar University - Assiut Branch.

Подробное описание

This is a pilot clinical trial designed to assess the feasibility and accuracy of augmented reality (AR)-guided mini-screw insertion in orthodontic patients. The study involves the use of CBCT imaging and digital intraoral scanning to create a 3D model of the patient's jaw. This model is then processed and integrated into an AR platform that allows real-time visualization of the ideal screw insertion site.

Participants are selected based on inclusion and exclusion criteria. After obtaining informed consent, CBCT and intraoral scans are performed. The proposed mini-screw location is determined digitally and projected using an AR device (tablet or headset) during the clinical procedure.

After insertion, a follow-up CBCT scan is taken to evaluate the deviation between the planned and actual screw positions (linear and angular deviation). Data on insertion time, patient comfort, and operator satisfaction will also be recorded.

The study is conducted at the Faculty of Dentistry, Al-Azhar University - Assiut Branch, with prior ethical approval obtained from the institutional review board.

Вмешательства

• Устройство Augmented Reality
  Participants in this group will undergo mini-screw placement assisted by augmented reality (AR) technology. A customized AR system will guide the clinician in real-time to ensure optimal screw positioning, improve accuracy, and minimize placement errors.
• Процедура Conventional screw placement
  Participants in this group will receive mini-screw placement using the conventional freehand method without augmented reality assistance. The screws will be placed according to standard clinical protocols based on anatomical landmarks and clinician experience

Первичные конечные точки

• Accuracy of screw placement [Срок оценки: 1 week post-op]

Критерии участия

Критерии включения

• 1\. Patients indicated for orthodontic mini-screw placement as part of their treatment plan.

2\. Age between 15 and 40 years.

3\. Good general health (ASA I or II).

4\. Adequate oral hygiene and healthy periodontal condition.

5\. Ability to understand and provide informed consent (or guardian consent for minors).

Критерии исключения

• 1 . Systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).

2\. History of craniofacial trauma, surgery, or congenital anomalies in the maxillofacial region.

3\. Ongoing periodontal disease or poor oral hygiene.

4\. Pregnancy or lactation.

5\. Use of medications influencing bone metabolism (e.g., bisphosphonates, corticosteroids).

6\. Allergy to local anesthetics or materials used in the procedure.

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 Dentistry — Asyut

Идентификаторы

NCT: NCT07112417 · AR-Ortho-MSc01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗