Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Accuracy of Implant Placement Using 3D Printed Registration Markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: D Printed Custom Registration Marker for Dynamic Navigation (Device)
Outcomes
Primary Outcomes
Accuracy of Implant Placement Using 3D Printed Registration Markers
Time Frame: Within 1 week after implant placement
Accuracy will be assessed by measuring deviations between the planned and actual implant positions using postoperative CBCT superimposed with the preoperative plan.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sherif Aly Sadek
Associate Professor
Cairo University