Stereolithographic Technique for Dentures

Completed

• Conditions: Mouth Edentulous; Jaw Edentulous

• Registration Number: NCT02911038
• Lead Sponsor: Corina Marilena Cristache

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 Poli(methylmetacrylate) - 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 0,4-1%TiO2 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 Timeline

• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Study Start: 2016-11
• Primary Completion: 2017-09
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients requiring mobile or removable dentures after establishing diagnosis and treatment plan, following initial clinical and laboratory examinations,
• Persons having mental competence, decision-making capacity, legal competence.
• Patients willing to accept complete denture treatment.
• Patients with good systemic health, able to attend all the follow-up sessions.
• Patients accepting the participation in the study, including the 18 months follow-up and signing the consent form.

Exclusion Criteria

• Patients do not agree the CAD-CAM technique for denture manufacturing.
• Patients refusing participation in the study and signing consent form.
• Patients not willing removable dental restorations.
• Patients not willing to participate at 18 months follow-up evaluation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)	up to 18 months	OHIP-EDENT-RO, validated for Romanian language questionnaire will be administrated at denture insertion and at 6, 12, 18 month follow-up

Secondary Outcome Measures

Name	Time	Method
Evaluation of denture changes in aesthetic aspect with VAS	up to 18 months	At 6, 12 and 18 months denture aesthetic will be evaluated using VAS with units from 0 to 10 where 0 is "totally satisfied" and 10 is "not at all satisfied".
Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)	up to 18 months	At 6, 12 and 18 months clinical follow-up masticatory performance will be evaluated using VAS with units from 0 to 10 where 0 is "totally satisfied" and 10 is "not at all satisfied".
Evaluation of changes in denture retention with VAS	up to 18 months	At 6, 12 and 18 months denture retention will be evaluated using VAS with units from 0 to 10 where 0 is "strong retention" ("totally satisfied") and 10 is "poor retention"("not at all satisfied").

Trial Locations

Locations (1)

"Carol Davila"University of Medicine and Pharmacy; 🇷🇴 Bucharest, Romania