Viewing Study NCT02911038



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Study NCT ID: NCT02911038
Status: COMPLETED
Last Update Posted: 2018-01-26
First Post: 2016-09-18

Brief Title: Stereolithographic Technique for Dentures
Sponsor: Corina Marilena Cristache
Organization: Concordia Dent Srl

Study Overview

Official Title: Stereolithographic Technique for Complete Denture Fabrication
Status: COMPLETED
Status Verified Date: 2018-01
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: PRIDENTPRO
Brief Summary: The aim of this observational study is producing complete dental prosthesis with the aid of CAD-CAM Computer aided design manufacturing - 3D printing Stereolithography technology - using as printable material Polimethylmetacrylate - PMMA - with Nano TiO2 nanoparticles composite completely characterized
Detailed Description: In order to improve complete dentures fabrications an experimental model for optimizing the composite material and the execution technique for the 3D printed dental prosthesis was developed

A new polymer - nano-TiO2 composite system for dentures printing was obtained by adding 04-1TiO2 nanoparticle in the commercially available E-Dent 100 EnvisionTEC Germany
The new polymer was completely characterized and biocompatibility tests were perform
A stereolithography technique was set-up for CAD-CAM complete dentures manufacturing
3D printed dental prosthesis will be inserted to a number of 35 complete edentulous patients from a target group
Clinical follow-up at 6 12 and 18 months and quality assessment of the dentures will be recorded in a specific chart
A statistical evaluation of data recorded during the entire follow-up period will be performed

Study Oversight

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