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This clinical study aims to evaluate implant deviation during immediate implant placement using dynamic navigation. By utilizing implant planning software, two CBCT scans (preoperative and postoperative) will be superimposed to assess the accuracy of dynamic navigation in immediate implant placement, which is considered a more complex procedure compared to delayed implant placement
First, a fiducial marker will be placed in the patient's mouth, followed by a CBCT scan with the marker in position. The implant will then be virtually planned using implant planning software. Using the MiniNaviDent system and the fiducial marker, the implant will be placed. After placement, a postoperative CBCT scan will be obtained. The postoperative scan will be superimposed onto the preoperative scan to measure implant deviation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic navigation-guided implant placement | Experimental | Dental implant osteotomy preparation and implant insertion performed using a dynamic navigation system to guide implant placement in real time according to the digital plan (CBCT-based planning with intraoperative navigation guidance) |
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| Static guided implant placement | Active Comparator | Implant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic navigation system-assisted dental implant placement | Device | Dental implant placement performed using a dynamic computer-assisted navigation system with real-time guidance. The implant position is planned pre-operatively using CBCT (and intraoral scan data if applicable). During surgery, the system tracks the patient reference and the drill/handpiece and displays real-time guidance to follow the planned implant trajectory for osteotomy preparation and implant insertion. Device name: mini Navident |
| Measure | Description | Time Frame |
|---|---|---|
| Coronal deviation (mm) Apical deviation (mm) | Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in millimeters (mm) | Pre-op CBCT and post-op CBCT within 7 days after surgery |
| Angular deviation (degrees) | Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in and the angular deviation in degrees was measured. | Pre-op CBCT and post-op CBCT within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total surgical time (minutes) | Total operative time recorded in minutes from first mucosal incision to completion of final implant insertion (last implant fully seated). Time will be recorded by an independent observer using a stopwatch and compared between the dynamic navigation and Static Guide groups | Intraoperative (day of surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Cairo Governorate | 11566 | Egypt |
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All participants will receive immediately placed implants following extraction
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| CAD/CAM static surgical guide-assisted dental implant placement | Device | Dental implant placement performed using a patient-specific CAD/CAM static surgical guide. The guide is designed from the digital implant plan (CBCT and, if applicable, intraoral scan) and fabricated (e.g., 3D printed). The static guide (with sleeves) is used to guide osteotomy preparation and implant insertion according to the planned implant position. |
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