Jaw Edentulous, Mouth Edentulous
Conditions
Keywords
Complete denture, PMMA, Stereolithography
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.
Interventions
None listed
Sponsors
Carol Davila University of Medicine and Pharmacy
Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
University Politechnica of Bucharest
TURKEY MEDISEN Ltd
DDX Europa SRL, Bucharest, Romania
Corina Marilena Cristache
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
Romania
Outcome results
None listed