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Completed

NCT Number: NCT03814655

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Full digital workflow

Procedure

Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.

Partially digital workflow

Procedure

Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Concordia Dent Srl

Other

Collaborators

  • Carol Davila University of Medicine and Pharmacy
  • MINEC

Registry information

Official study title

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

Acronym: DIGIMPLGD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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