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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

25

Phase

  • 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

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
Intervention / Treatment
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

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

Concordia Dent Srl

Collaborators

Carol Davila University of Medicine and Pharmacy
MEGAGEN DENTAL IMPLANT ROMANIA

Investigators

  • 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

July 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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