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Completed

NCT Number: NCT02217774

MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

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.

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Key information

Conditions

Focus of Study: Computer-Aided Design/Instrumentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, 3109601, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

MGUIDE MORE

Device

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • MIS Implant Technologies, Ltd

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 15, 2014
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.