MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

Conditions
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Focus of Study: Computer-Aided Design/Instrumentation

Intervention / Treatment
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* Device: MGUIDE MORE


Participation Criteria
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Eligibility Criteria
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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: -

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGUIDE assisted implant placement<br>Implant placement, using MGUIDE MORE system for implant planning and placement | Device: MGUIDE MORE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation from planning | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer-Aided Design/instrumentation, Cone-Beam Computed Tomography, Dental Implant, MGuide