Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Marginal Adaptation
研究概览
简要总结
Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.
详细描述
A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations will be evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 25 subject will be randomly assigned to each group for a total of 50 subject. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.
Both groups will receive Inlay/Onlay preparation . Digital impression will be taken, wax pattern for the Inlay/Onlay restoration will be designed and milled using CAD/CAM(computer-aided design/computer-aided manufacturing) software. After that, the wax pattern will be invested and final Inlay/Onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded (Patient and outcome assessors)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is healthy.
- •18-50 years old.
- •Normal occlusion.
- •Good oral hygiene.
- •Tooth with complete root apex.
- •Tooth with moderate coronal decay.
排除标准
- •Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.
结局指标
主要结局
Marginal Adaptation
时间窗: 1 year follow up
Measuring device: visual and probe. According to FDI standard(Grade 1-5), which has been defined as follows: Grade 1. Harmonious outline, no gaps, no white or discolored lines. Grade 2. Marginal gap (\> 50 μm and \< 150 μm), white lines; small marginal fracture removable by polishing; slight ditching, slight step /flashes, minor irregularities Grade 3. Gap (\> 150 μm and \< 250 μm) not removable; several small marginal fractures; major irregularities, ditching or flash, steps. Grade 4. Gap (\> 250 μm) dentine/base exposed, chip fracture damaging margins, Notable enamel, or dentine wall fracture. Grade 5. Restoration is loose but in situ.
次要结局
- Restoration Fracture and retention(1 year follow up)
- Effect of the restoration on the periodontium(1 year follow up)
- Tooth cracks and fractures(1 year follow up)
研究者
Walid Awad Abdelhady
Assistant Lecturer, Department of Crown and Bridge, Al-Azhar University
Al-Azhar University