Stereolithographic Technique for Dentures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stereolithographic Technique for Complete Denture Fabrication

Conditions
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Mouth Edentulous, Jaw Edentulous

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS) | 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. | up to 18 months | 
| Evaluation of changes in denture retention with VAS | 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). | up to 18 months | 
| Evaluation of denture changes in aesthetic aspect with VAS | 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. | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complete denture, PMMA, Stereolithography