Accuracy of Computer Guided Implant Surgery (STIMPLANTSRG)

January 26, 2016 updated by: Corina Marilena Cristache, Concordia Dent Srl

Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template

The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level.

Clinical relevance:

  • To identify factors influencing the surgical template imprecision.
  • To overcome risk factors for surgical template imprecision.
  • To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Initial examination, panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients. For diagnosis accuracy, impression of the surgical site and the opposite arch is mandatory.

For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration.

CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation (CR).

CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility.

A series of axially sliced image data will be obtained and exported to a personal computer in DICOM (Digital Imaging and Communications in Medicine) format.

Models, occlusal rims and R2 trays will be scanned and imported as STL (Stereo Lithography) files.

On the scan models, a virtual wax-up will be designed with the use of 3Shape CAD (Computer Aided Design) software and saved as STL file.

Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 1.0.3 (Megagen Implant, Korea) and implant insertion will be planned according to the final restoration and bone anatomy.

AnyRidge Megagen implants will be used with length and diameters required by the clinical cases.

A stereolitographic template manufactured by DDX Europa, after final decision of treatment plan, will be used for dental implants insertion using a minimally invasive flapless approach.

To assess accuracy of the surgical template, a new CBCT with specific set-up and alignment after implant insertion will be performed.

Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal by two independent researchers. Angulation between the implant position and the planned position at coronal and apical level will be also measured.

Statistical analysis will be performed. Teeth supported, mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 041335
        • Concordia Dent Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fully or partially edentulous patients,
  • good general healty with no contraindications for implant surgery,
  • acceptance of dental implant treatment,
  • acceptance of at least 2 CBCT (one at treatment planning and one after surgery)

Exclusion Criteria:

  • limited bone volume with stadial bone graft requirement,
  • limited mouth opening (imposible to use the surgical stent),
  • parkinson desease (imposible to perform an accurate CBCT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stereolitographic template's accuracy
Evaluating the accuracy of stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level
Other: Stereolitographic template
Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurements of accuracy after implants placement at coronal and apical level
Time Frame: average 10 days
Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.
average 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concordia Dent Srl

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carol Davila University of Medicine and Pharmacy
MEGAGEN DENTAL IMPLANT ROMANIA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CORINA MARILENA I CRISTACHE, DMD, PhD, Carol Davila University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 613/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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