Dynamic Navigation-Assisted Dental Implant Placement

Not Applicable

Completed

• Conditions: Dental Implants, Surgery, Computers
• Interventions: Procedure: Freehand Implant Surgery; Device: Dynamic Navigation Assisted Implant Surgery

• Registration Number: NCT03471208
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Study First Submitted: 2018-02-22
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-19
• Study First Posted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freehand	Freehand Implant Surgery	Dental implant surgery via conventional freehand
Dynamic Navigation	Dynamic Navigation Assisted Implant Surgery	Dental implant surgery via dynamic navigation assistance

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Damage to the surrounding critical anatomy	1 day (On the day of surgery).	Any damage to the sinus maxillaries