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.
研究组 & 干预措施
flowable resin-composite
3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites.
other names: ''flowable composite ''
干预措施: flowable resin composite (Other)
self-adhering flowable
intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system
干预措施: self adhering flowable (Other)
self-adhering flowable with adhesive
intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance
干预措施: self adhering flowable with adhesive (Other)
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