Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Success Rate
研究概览
简要总结
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
详细描述
The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's age between 18 and 65 years old
- •Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
- •Vital teeth
- •2 restorations per patient: both cavities should have comparable size and dimensions
- •Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
- •Low to moderate caries rate/normal periodontal status with good home care
排除标准
- •Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
- •Pulp exposure or signs of pulpal infection
- •No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)
- •History of allergy to glass ionomer, acrylate/methacrylate monomers
- •Pregnancy
- •Chronic disease with oral manifestations or primary oral pathology
- •Bad oral hygiene
- •High caries rate or periodontal problems
- •Absence of antagonists
- •Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)
结局指标
主要结局
Success Rate
时间窗: 5 years
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)
次要结局
- Survival Rate(6 months to 5 years)
- Success Rate(6 months to 3 years)
- Quality criteria (Clinical performance)(6 months to 5 years)