MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

September 27, 2017 updated by: Rambam Health Care Campus
The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by evaluating the difference between planned and actual implant positions on pre- and post-operative CBCTs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients, attending the Department of Periodontology at the Rambam School of Graduate Dentistry, who are scheduled for implant therapy, will be screened for the study. Patients will be referred for CBCT of the upper/lower jaw as appropriate. DICOM data of the patient will be uploaded to MGUIDE software and used for diagnosis and treatment planning of the case. Surgery will be performed using MGUIDE MORE template and MGUIDE MORE surgical kit. Pre-operative and post-operative CBCT will be used for assessment of the difference between planned and actual implant positions.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated inform consent form.
  • Age between 18+.
  • Patient expresses his wish to restore the missing tooth/teeth with dental implants.
  • Patient is examined and found suitable for implant therapy
  • Patient can open mouth sufficiently for preparation and placement of dental implants using the contra-angle handpiece and drills.
  • CBCT is required for proper diagnosis and treatment planning.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGUIDE assisted implant placement
Implant placement, using MGUIDE MORE system for implant planning and placement
Device: MGUIDE MORE
MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template, will be used for planning, drilling and inserting dental implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation from planning
Time Frame: 0-14 days after implant placement
To assess shoulder and apex deviations in milimeters between planned and actual implant position and to assess angular deviation in degrees, of actual implant position vs. planned implant position
0-14 days after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

MIS Implant Technologies, Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 23, 2015

Study Completion (Actual)

August 23, 2015

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0210-14-RMB CTIL
  • 0210-14-RMB (Other Identifier: Rambam Health Care Campus Internal Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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