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MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

NCT ID: NCT02217774

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-23

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.

Conditions

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Focus of Study: Computer-Aided Design/Instrumentation

Keywords

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Computer-Aided Design/instrumentation Cone-Beam Computed Tomography Dental Implant MGuide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MGUIDE assisted implant placement

Implant placement, using MGUIDE MORE system for implant planning and placement

Group Type EXPERIMENTAL

MGUIDE MORE

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MIS Implant Technologies, Ltd

INDUSTRY

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Horwitz, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

References

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Horwitz J, Zuabi O, Machtei EE. Accuracy of a computerized tomography-guided template-assisted implant placement system: an in vitro study. Clin Oral Implants Res. 2009 Oct;20(10):1156-62. doi: 10.1111/j.1600-0501.2009.01748.x. Epub 2009 Jun 10.

Reference Type BACKGROUND
PMID: 19519787 (View on PubMed)

Other Identifiers

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0210-14-RMB

Identifier Type: OTHER

Identifier Source: secondary_id

0210-14-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id