Viewing Study NCT03814655



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Last Modification Date: 2024-10-26 @ 1:02 PM
Study NCT ID: NCT03814655
Status: COMPLETED
Last Update Posted: 2020-07-14
First Post: 2019-01-20

Brief Title: Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software
Sponsor: Concordia Dent Srl
Organization: Concordia Dent Srl

Study Overview

Official Title: Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial RCT
Status: COMPLETED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIGIMPLGD
Brief Summary: 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None