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

Sherif Aly Sadek

Status: Enrolling

Conditions: Dental Implantation Accuracy

Treatments: Device: D Printed Custom Registration Marker for Dynamic Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07199153

22-4-24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

3D Printed Registration for Dynamic Navigation Surgery

Experimental group

Description:

Participants with a single missing anterior maxillary tooth will undergo implant placement using the Mininavident dynamic navigation system with a custom-made, 3D printed registration marker. The marker enables registration of CBCT and intraoral scans for prosthetically driven implant planning and real-time guided surgery.

Treatment:

Device: D Printed Custom Registration Marker for Dynamic Navigation