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Clinical Trials/NCT03471208
NCT03471208
Completed
Not Applicable

Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand

Istanbul University0 sites32 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implants, Surgery, Computers
Sponsor
Istanbul University
Enrollment
32
Primary Endpoint
Change between the planned and placed implant positions
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
January 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Volkan Arisan

Dr. Volkan Arısan

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Damage to the surrounding critical anatomy(1 day (On the day of surgery).)

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