At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Accuracy of Partially or Fully Guided Dental Implantation Performed With Dental Implantological Surgical Guide as Compared to Freehand Dental Implantation
In Brief
A clinical study evaluating SMART Guide for Dental Implantation, Endosseous and 4 related conditions. Completed, enrolled 119 participants across 1 site.
Detailed Summary
This is a prospective, adaptive, parallel study with four arms, which seeks to compare the accuracy of freehand and guided dental implantation surgeries. The basis of the comparison in each case is a digital plan, and that digital plan is compared to the actual postoperative status by computerized, three dimensional analysis.
Study Details
Timeline
Interventions
The device manufactured according to a digital plan based on patient anatomy. Guiding sleeves are used, through which bone drills are applied. These sleeves sit in a plastic template that is a negative of the patient's dentition, so that the guide is properly stabilized during the operation. The position of the sleeves is calculated from the surgical plan in a way that they guide the drills in the planned position.The material of the template is medical plastic, the sleeves are made of medical steel.The device is applied by the dentist during the implant surgery. The template is placed on the remaining dentition of the patient and stabilized this way. By this, the sleeves are also stabilized in their planned position. Access through the soft tissue can be prepared through the given sleeve with a circular trephine, but the system also supports flap surgery. As access has been established, the dentist performs the surgical protocol as planned.