Evaluation of 3D Printed Polyether Ether Ketone (PEEK) and Milled PEEK Indirect Restorations Compared to Hybird Resin Composite Indirect Restorations Over One Year Period of Time ( A Randomized Clinical Trial )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting)
研究概览
简要总结
Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time
详细描述
The aim of this study is to evaluate fracture and retention, wear of 3D printed PEEK indirect restorations and milled PEEK indirect restorations compared to milled indirect hybrid resin composite restorations according to FDI criteria over one year.
According to indirect restorations cavity preparation principles, shade selection and occlusal examination will be done preoperatively, followed by cavity preparations that will be carried out with tapered diamond stones.
The prepared teeth for the indirect restorations will be scanned with an optical scanner. Then restorations will be designed by a CAD software and files will be made in STL format, so as to be ready for either 3D printing or milling with different materials.
While the printed PEEK restorations are additively made, the milled PEEK and hybrid composite restorations are both milled out of either a disc or block ( size 12) using a CAD/CAM milling machine.
After the printing and the milling procedures are complete, the restorations are then promptly removed. Each restoration will be assessed and adjusted for its cavity after the occlusal surface is recontoured. This post-processing adjustments will be applied to both 3d printed ones and milled restorations. After assessment and needed adjustments are done, all restorations will be cemented into the cavities in accordance with the manufacturer's recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aging (18-45) years.
- •Patients with a high level of oral hygiene.
- •Each patient enrolled in the study should have moderate carious lesion or defective restoration needs to be replaced on a mandibular permanent molar.
- •Patients with ability to attend periodical follow-ups.
排除标准
- •Patients with general/systemic diseases or allergies.
- •Patients with chronic use of anti- inflammatory, analgesic, and psychotropic drugs.
- •Pregnant or lactating females.
- •Patients with parafunctional habits.
- •Patients with experience of allergic reactions against any components of the used materials.
- •Patients receiving orthodontic treatment.
- •Inability to comply with study procedures.
- •Collateral participation in another research study.
结局指标
主要结局
Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting)
时间窗: Baseline, 6 months, 12 months
Outcome:Fracture of the material and retention Measuring device: Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting. (Hickel et al., 2023) Measuring unit: Scoring system (Ordinal) 1. Clinically excellent/very good (sufficient) 2. Clinically good (sufficient) 3. Clinically satisfactory (sufficient) 4. Clinically unsatisfactory (partially insufficient) 5. Clinically poor (entirely insufficient)
次要结局
- occlusion and wear (Category F5)(Baseline, 6 months, 12 months)
研究者
Hadeer Ahmed Abdalnaby Ahmed Attia
Lecturer Assistant at MSA UNIVERSITY
Cairo University