Comparing the Clinical Success of Milled and 3-D Printed Composite CAD/CAM Full Cuspal Coverage Onlays
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- The rate of survival of the onlays at the specific time points
研究概览
简要总结
This is a single-center, ten-year, randomized controlled, split-mouth clinical trial. A total of 164 adult patients requiring full-cuspal coverage onlays will be enrolled. Each participant will receive one milled and one 3-D printed restoration, randomly assigned.
详细描述
Restorations will be evaluated at 1 week, 6 months, and 1-10 years using the revised FDI criteria for indirect restorations. The primary outcome is the survival rate of the onlays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of two teeth requiring restorative treatment (onlays) because of primary or secondary caries or final restoration is needed after root canal treatment, with adjacent and antagonist teeth
- •At least two walls (buccal and oral) with a minimum length of 2.5 mm and a width of 2 mm
- •The deepest point of the tooth structure should be above a minimum of 3 mm of supracrestal
- •The crown-to-root ratio is minimum 1:1
排除标准
- •Inadequate oral hygiene
- •Pregnancy
- •Allergies to restorative materials
- •Parafunctional habits (e.g., teeth grinding or clenching)
- •Presence of orthodontic appliances
- •Premolars that have undergone root canal treatment
研究组 & 干预措施
3D-printed
3-D printed CAD/CAM composite restorations
干预措施: full cuspal covarage onlay (Device)
Milled
Milled CAD/CAM composite restorations
干预措施: full cuspal covarage onlay (Device)
结局指标
主要结局
The rate of survival of the onlays at the specific time points
时间窗: Survival will be evaluated at specific follow-up time points (1 week, 6 months, 1 year - 10 years)
The survival of the onlays will be assessed at the patient level with the revised FDI criteria for direct and indirect restorations.
次要结局
未报告次要终点
研究者
Eszter Á Szalai, DMD
assistant lecturer
Semmelweis University