Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial

Обзор

This clinical trial evaluates the accuracy of a 3D printed custom-made registration method for dynamic navigation implant surgery using the Mininavident system in the esthetic zone of the anterior maxilla. Ten patients with a single missing anterior tooth will undergo CBCT-based planning, intraoral scanning, and guided implant placement using 3D printed registration markers. Postoperative CBCT analysis will measure deviations between planned and placed implants in terms of angular, coronal, and apical positions. The study aims to determine whether 3D printed markers provide clinically acceptable accuracy (\<2 mm, \<5°) and to assess their feasibility as a reproducible alternative to standard registration methods.

Подробное описание

Accurate implant positioning is essential for esthetic and functional success, particularly in the anterior maxilla. Dynamic navigation systems (DNS) provide real-time guidance but depend on reliable registration between patient anatomy and virtual planning. Errors may occur with conventional fiducial markers, highlighting the need for more precise methods.

This clinical trial investigates the use of 3D printed custom registration markers with the Mininavident DNS for implant placement in the esthetic zone. Ten patients with a single missing anterior tooth will undergo CBCT-based planning and guided implant placement using the custom markers. Postoperative CBCT scans will be compared with preoperative plans to measure positional and angular deviations.

The primary outcome is the accuracy of implant placement, with deviations expected to remain within clinically acceptable limits (\<2 mm, \<5°). Secondary outcomes include assessing the feasibility and reproducibility of incorporating 3D printed registration into DNS workflows. Results may validate this approach as a cost-effective, patient-specific solution to enhance precision and predictability in implant dentistry.

Вмешательства

• Устройство D Printed Custom Registration Marker for Dynamic Navigation
  A patient-specific, 3D printed registration marker designed for use with the Mininavident dynamic navigation system. The marker is fabricated based on CBCT and intraoral scans, enabling accurate registration between virtual planning and clinical implant placement in the esthetic zone. Accuracy of placement is assessed through postoperative CBCT superimposition.

Первичные конечные точки

• Accuracy of Implant Placement Using 3D Printed Registration Markers [Срок оценки: Within 1 week after implant placement]

Критерии участия

Критерии включения

• Single missing tooth in the anterior maxilla
• ≥12 mm bone height and ≥5.5 mm width
• D3 bone density
• Angle's Class I occlusion
• No systemic contraindications to implant surgery

Критерии исключения

• Heavy smoking or uncontrolled diabetes
• Radiation therapy involving the head and neck
• Parafunctional habits (e.g., bruxism)
• Class III malocclusion or edge-to-edge bites

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Cairo University — Cairo

Идентификаторы

NCT: NCT07199153 · 22-4-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗