Focus of Study: Computer-Aided Design/InstrumentationNCT02217774
MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study
A study testing MGUIDE MORE in people with Focus of Study: Computer-Aided Design/Instrumentation, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Computer-Aided Design/Instrumentation
- What is being tested?
- MGUIDE MORE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to 23 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed 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.
- Being tested
- MGUIDE MORE
- Keywords
- Computer-Aided Design/instrumentation, Cone-Beam Computed Tomography, Dental Implant, MGuide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MGUIDE assisted implant placement | Experimental | Implant placement, using MGUIDE MORE system for implant planning and placement Receives: Device: MGUIDE MORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-14 days after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startNov 2014
- Primary completion23 Aug 2015
- Study completion23 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: Computer-Aided Design/InstrumentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- MIS Implant Technologies, Ltd
- Responsible party
- Sponsor
- Investigators
- Jacob Horwitz, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217774
- Sponsor's protocol ID
- 0210-14-RMB CTIL
- Other IDs
- 0210-14-RMB
- Status last verified
- Sep 2017
- First submitted
- 12 Aug 2014
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19519787
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study
- ClinicalTrials.gov ID
- NCT02217774
- Acronym / sponsor ID
- 0210-14-RMB CTIL
- Keywords
- Computer-Aided Design/instrumentation, Cone-Beam Computed Tomography, Dental Implant, MGuide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- MIS Implant Technologies, Ltd
- Study start
- Nov 2014
- Primary completion
- 23 Aug 2015 (actual)
- Study completion
- 23 Aug 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGUIDE assisted implant placement | Experimental | Device: MGUIDE MOREImplant placement, using MGUIDE MORE system for implant planning and placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGUIDE MOREMGUIDE 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. | Device | MGUIDE assisted implant placement |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Background: PubMed 19519787Horwitz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Horwitz, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGUIDE MORE in people with Focus of Study: Computer-Aided Design/Instrumentation, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation from planning (time frame: 0-14 days after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.