Stereolithographic Technique for Complete Denture Fabrication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)
时间窗: 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
次要结局
- Evaluation of denture changes in aesthetic aspect with VAS(up to 18 months)
- Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)(up to 18 months)
- Evaluation of changes in denture retention with VAS(up to 18 months)
研究者
Corina Marilena Cristache
Senior Lecturer, PhD, Dr
Concordia Dent Srl