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OpenTrials
Completed

NCT Number: NCT03471208

Dynamic Navigation-Assisted Dental Implant Placement

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.

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Key information

Conditions

Dental Implants, Surgery, Computers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dynamic Navigation Assisted Implant Surgery

Device

Implant surgery using dynamic navigation assistance

Freehand Implant Surgery

Procedure

Dental implant surgery via conventional freehand

Other names: Dental implant surgery via conventional freehand

Primary outcomes

  1. 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

  1. Damage to the surrounding critical anatomy

    Time frame: 1 day (On the day of surgery).

    Any damage to the sinus maxillaries

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2018
Registry last updated
Mar 21, 2018

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.