Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Clinical performance restoration
研究概览
简要总结
To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.
详细描述
A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.
The study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must have given written informed consent to participate in the trial
- •need at least three posterior restorations
- •must be available for the required post-operative follow-up visits
- •have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
- •At least one occlusal and proximal contact on a natural tooth
- •Cavities depth > 2 mm in cervico-occlusal
排除标准
- •have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations
- •have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
- •chronic periodontitis
- •present with any systemic or local disorders that contra-indicate the dental procedures included in this study
- •an unstable occlusion
- •severe bruxing
- •teeth with periapical pathology or expected pulp exposures
- •are pregnant.
- •Endodontically treated teeth
研究组 & 干预措施
Bulk-Fill composite Class I, II and V cavities
Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V
干预措施: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite (Device)
Bulk-Fill composite Class I, II and V cavities
Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V
干预措施: Z 350 Xt Composite (Device)
Z 350 xt Composite
Restorative with Z 350 xt composite in class I, II and V
干预措施: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite (Device)
Z 350 xt Composite
Restorative with Z 350 xt composite in class I, II and V
干预措施: Z 350 Xt Composite (Device)
结局指标
主要结局
Clinical performance restoration
时间窗: six month, one years, two, three, four and five years
Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.
次要结局
未报告次要终点
研究者
Patricio Vildosola Grez
Associate Professor
Universidad Nacional Andres Bello