MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

Focus of Study: Computer-Aided Design/Instrumentation Clinical Trial

Official title:

MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217774
• Other study ID #: 0210-14-RMB CTIL
• Secondary ID: 0210-14-RMB
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: September 27, 2017
• Start date: November 2014
• Est. completion date: August 23, 2015

Study information

• Verified date: September 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 23, 2015
• Est. primary completion date: August 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Focus of Study: Computer-Aided Design/Instrumentation

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	MIS Implant Technologies, Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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