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

NCT07199153 | Recruiting

• 1 other identifier: 22-4-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implantation Accuracy

Keywords

Dynamic Navigation Surgery; Dental Implant Surgery; Implant Accuracy; Esthetic Zone; Computer-Guided Implantology; Digital Dentistry; Prosthetically Driven Implant Planning

Outcome Measures

Primary Outcomes (1)

• Accuracy of Implant Placement Using 3D Printed Registration Markers

  Accuracy will be assessed by measuring deviations between the planned and actual implant positions using postoperative CBCT superimposed with the preoperative plan.

  Within 1 week after implant placement

Study Arms (1)

3D Printed Registration for Dynamic Navigation Surgery

EXPERIMENTAL

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.

Device: D Printed Custom Registration Marker for Dynamic Navigation

Interventions

D Printed Custom Registration Marker for Dynamic Navigation 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.

3D Printed Registration for Dynamic Navigation Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherif Aly Sadek: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Hala Soliman

CONTACT

+201006788228; hala.zakaria@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 30, 2025
• Study Start: August 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 15, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)