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A Study of a Surgical Guide for Dental Implantology

NCT03854162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Dental Implantation, Endosseous
  • Dental Implants
  • Minimally Invasive Surgical Procedures
  • Surgery, Oral
  • Surgery, Computer-Assisted

Interventions

DEVICE

SMART Guide

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.

Sponsors & Collaborators

  • Alpha - Bio Tec Ltd.

    collaborator INDUSTRY

  • dicomLAB Ltd.

    collaborator UNKNOWN

  • Szeged University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2018-11-30
Completion
2019-02-28

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854162 on ClinicalTrials.gov