Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software (DIGIMPLGD)

July 13, 2020 updated by: Corina Marilena Cristache, Concordia Dent Srl

Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)

The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure.

Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing.

The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned.

For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.

Study Type

Interventional

Enrollment (Actual)

54

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
      • Bucharest, Romania
        • "Carol Davila"University of Medicine and Pharmacy

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

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Kennedy Class III partially edentulism with 3 or less missing teeth,
  • Good general health with no contraindications for implant surgery,
  • Acceptance of dental implant treatment,
  • Acceptance of 1 or 2 CBCTs.

Exclusion Criteria:

  • Limited bone volume with stadial bone graft requirement,
  • Limited mouth opening (impossible to use the surgical stent),
  • Parkinson disease (impossible 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full digital workflow
  1. Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch.
  2. CBCT with customized radiopaque tray.
  3. Merging files in R2 Gate software and implant planning.
  4. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
  5. Digital impression for final screw-retained crown/bridge.
  6. Assessment of accuracy by comparing stl files (planned and postimplant insertion).
Procedure: Full digital workflow
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
Active Comparator: Partially digital workflow
  1. Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch.
  2. CBCT with customized radiopaque tray.
  3. Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner.
  4. Merging files (CBCT and model stl) in R2 Gate software and implant planning.
  5. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
  6. Classic impression in customized tray with Impregum.
  7. Functional models will be scanned using the same desktop scanner.
  8. Final screw-retained crown/bridge manufacturing.
  9. Assessment of accuracy by comparing stl files (planned and postimplant insertion).
Procedure: Partially digital workflow
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of dental implant insertion
Time Frame: 6 weeks

Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision.

Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.
6 weeks

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
MINEC

Investigators

  • Principal Investigator: Corina Marilena 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 (Actual)

July 1, 2019

Primary Completion (Actual)

February 15, 2020

Study Completion (Actual)

July 13, 2020

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

January 20, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINEC 2/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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