Evaluation of Micro -Tensile Bond Strength to Dentin and Color Stability of a New Self Adhesive Bulk-fill Resin Composite Restorative Material After Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.
研究概览
简要总结
The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).
详细描述
For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.
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, Care Provider)
盲法说明
This study is a prospective randomized clinical trial with a follow up of 6 months. The clinical examiner and the participant will be kept unaware of the treatment being administrated.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.
- •Patients with teeth shade A2 according to Vitapan classical shade guide.
- •Patients with an acceptable oral hygiene level.
- •Patients keen to regularly attend the follow up visits.
排除标准
- •Patients with heavy bruxism or traumatic occlusion.
- •Patients with poor oral hygiene or active periodontal disease.
- •Patients with exposed or endodontically treated teeth.
- •Patients participated in a clinical trial within 6 months before beginning of this trial.
- •Patients who decline to be involved in the study or sign the written consent.
- •Patients unable to return for the follow up visits.
结局指标
主要结局
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.
时间窗: 6 months
Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.
次要结局
未报告次要终点
研究者
Nourhan Samir Soliman Ibrahim
Dr
Minia University