Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes
研究概览
简要总结
With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.
详细描述
flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with anterior cervical carious lesions.
- •Pulp asymptomatic vital carious anterior teeth.
- •Co-operative patients approving to participate in the trial.
排除标准
- •Pregnancy.
- •Disabilities.
- •Systemic disease or severe medical complications.
- •Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
- •Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- •Heavy smokers.
结局指标
主要结局
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes
时间窗: Change from the baseline at 6 months and12 months]
Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health). Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form). Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor). Subscales will not be combined
次要结局
未报告次要终点
研究者
Mona Mounir Ibrahim Hassan
assistant lecturer
Cairo University