Dynamic Navigation-Assisted Dental Implant Placement

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Implants, Surgery, Computers

Intervention / Treatment
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* Device: Dynamic Navigation Assisted Implant Surgery
* Procedure: Freehand Implant Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dental implant surgery assisted by a stereotaxic surgical instrument
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Navigation<br>Dental implant surgery via dynamic navigation assistance | Device: Dynamic Navigation Assisted Implant Surgery<br>* Implant surgery using dynamic navigation assistance<br>|
| Active Comparator: Freehand<br>Dental implant surgery via conventional freehand | Procedure: Freehand Implant Surgery<br>* Dental implant surgery via conventional freehand<br>* Other names: Dental implant surgery via conventional freehand;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Damage to the surrounding critical anatomy | Any damage to the sinus maxillaries | 1 day (On the day of surgery). |