Dynamic Navigation-Assisted Dental Implant Placement

Overview

Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach. All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.

Full Title of Study: “Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 1, 2018

Interventions

  • Device: Dynamic Navigation Assisted Implant Surgery
    • Implant surgery using dynamic navigation assistance
  • Procedure: Freehand Implant Surgery
    • Dental implant surgery via conventional freehand

Arms, Groups and Cohorts

  • Experimental: Dynamic Navigation
    • Dental implant surgery via dynamic navigation assistance
  • Active Comparator: Freehand
    • Dental implant surgery via conventional freehand

Clinical Trial Outcome Measures

Primary Measures

  • Change between the planned and placed implant positions
    • Time Frame: 12 weeks
    • Deviations between the planned and placed implants will be measured by matching the pre- and post-op tomographic images.

Secondary Measures

  • Damage to the surrounding critical anatomy
    • Time Frame: 1 day (On the day of surgery).
    • Any damage to the sinus maxillaries

Participating in This Clinical Trial

Inclusion Criteria

  • men and women aged >18 years. – Patients approving to participate in the trial and giving written consent – must be able to open his/her mouth Exclusion Criteria:

  • Hemodynamically significant mitral valve stenosis – Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted) – Planned cardioversion (electrical or pharmacological) – Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion) – Known presence of atrial myxoma or left ventricular thrombus – Active endocarditis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Istanbul University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Volkan Arisan, Dr. Volkan Arısan – Istanbul University

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