NCT02217774

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2015

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

August 12, 2014

Last Update Submit

September 27, 2017

Conditions

Focus of Study: Computer-Aided Design/Instrumentation

Keywords

Computer-Aided Design/instrumentationCone-Beam Computed TomographyDental ImplantMGuide

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MGUIDE assisted implant placement

EXPERIMENTAL

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

Device: MGUIDE MORE

Interventions

MGUIDE MOREDEVICE

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.

MGUIDE assisted implant placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Related 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.

    PMID: 19519787BACKGROUND

Study Officials

  • Jacob Horwitz, DMD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

November 1, 2014

Primary Completion

August 23, 2015

Study Completion

August 23, 2015

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

IL(1)