Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D Printed Custom Registration Marker for Dynamic Navigation.
- Who it may be relevant to
- Registry conditions: Dental Implantation Accuracy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Accuracy of Implant Placement Using 3D Printed Registration Markers [Time frame: Within 1 week after implant placement]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07199153 · 22-4-24