An Immediate Implant Will be Placed Using the MiniNaviDent System and Static Guide. A Postoperative CBCT Scan Will Then be Acquired and Superimposed Onto the Preoperative CBCT Scan to Assess and Compare Implant Deviation Relative to the Preoperative Plan

NCT07380360 | Completed DMC

• 1 other identifier: FDASU-RecIM012333
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Remaining Root; Tooth Extraction

Keywords

immediate implant; dynamic navigation; static guide; CBCT superimposition; guided implant surgery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Total surgical time (minutes)

  Intraoperative (day of surgery)

Study Arms (2)

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)

Device: Dynamic navigation system-assisted dental implant placement

Static guided implant placement

ACTIVE COMPARATOR

Implant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan.

Device: CAD/CAM static surgical guide-assisted dental implant placement

Interventions

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

Dynamic navigation-guided implant placement

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.

Static guided implant placement

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients at least 21 years old.
• Systemically healthy patients with no effect on the surgery.
• At least one hopeless maxillary or mandibular tooth to be restored using an implant.
• At least six residual teeth in the affected jaw.

You may not qualify if:

• A medical condition or medication that would impair bone healing.
• Poor oral hygiene
• Alcohol users.
• Smoking more than 10 cigarettes per day.
• History of head and neck radiotherapy.
• Pregnant females.
• Uncontrolled hypertensive or diabetic patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive immediately placed implants following extraction

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 2, 2026
• Study Start: November 24, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

EG (1)