Remaining Root, Tooth Extraction
Conditions
Keywords
immediate implant, dynamic navigation, static guide, CBCT superimposition, guided implant surgery
Brief summary
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
Detailed description
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.
Interventions
DEVICEDynamic navigation system-assisted dental implant placement
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
DEVICECAD/CAM static surgical guide-assisted dental implant placement
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.
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
All participants will receive immediately placed implants following extraction
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy patients at least 21 years old. 2. Systemically healthy patients with no effect on the surgery. 3. At least one hopeless maxillary or mandibular tooth to be restored using an implant. 4. At least six residual teeth in the affected jaw.
Exclusion criteria
1. A medical condition or medication that would impair bone healing. 2. Poor oral hygiene 3. Alcohol users. 4. Smoking more than 10 cigarettes per day. 5. History of head and neck radiotherapy. 6. Pregnant females. 7. Uncontrolled hypertensive or diabetic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronal deviation (mm) Apical deviation (mm) | Pre-op CBCT and post-op CBCT within 7 days after surgery | 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) |
| Angular deviation (degrees) | Pre-op CBCT and post-op CBCT within 7 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total surgical time (minutes) | Intraoperative (day of surgery) | 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 |
Countries
Egypt
Outcome results
None listed