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

NCT ID: NCT07199153

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2025-10-15

Brief Summary

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.

Detailed 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.

Conditions

Dental Implantation Accuracy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D Printed Registration for Dynamic Navigation Surgery

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.

Group Type: EXPERIMENTAL

D Printed Custom Registration Marker for Dynamic Navigation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Sherif Aly Sadek

OTHER

Sponsor Role: lead

Responsible Party

Sherif Aly Sadek

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hala Soliman

Role: CONTACT

hala.zakaria@dentistry.cu.edu.eg

+201006788228

Facility Contacts

Hala Soliman

Role: primary

hala.zakaria@dentistry.cu.edu.eg

+201006788228

Other Identifiers

22-4-24

Identifier Type: -

Identifier Source: org_study_id