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Completed

NCT Number: NCT07380360

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

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

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Key information

Conditions

Remaining Root Tooth Extraction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Cairo Governorate, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Coronal deviation (mm) Apical deviation (mm)

    Time frame: 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)

  2. Angular deviation (degrees)

    Time frame: 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 outcomes

  1. Total surgical time (minutes)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Immediate Implant Placement Accuracy Using a Dynamic Navigation System. "Randomized Clinical Trial"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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