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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

A

Ain Shams University

Status

Completed

Conditions

Dynamic Navigation
Static Guide

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07380360
FDASU-RecIM012333

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Dynamic navigation-guided implant placement
Experimental group
Description:
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)
Treatment:
Device: Dynamic navigation system-assisted dental implant placement
Static guided implant placement
Active Comparator group
Description:
Implant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan.
Treatment:
Device: CAD/CAM static surgical guide-assisted dental implant placement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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