The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Recurrent caries
研究概览
简要总结
Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults patients (20-50)
- •Good oral hygiene (plaque index 0 or 1 )
- •Patient approving to participate in the study
- •Absence of parafunctional habits and/or bruxism
- •No sign of irreversible pulpitis
- •No periapical radiolucency
- •Deep subgingival margin
- •Molars class II with subgingival margin
排除标准
- •• Patients with known allergic or adverse reaction to the tested materials.
- •Systematic disease that may affect participation.
- •Xerostomic patients.
- •Bad oral hygiene (plaque index 2 or 3 )
- •Heavy smokers
- •Patients undergoing or will start orthodontic treatment
- •Patients with removable prothesis
结局指标
主要结局
Recurrent caries
时间窗: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
* 0: no evidence of caries continuous along the margin using periapical radiograph. * 1: caries evident continuous with the margin of restoration
次要结局
- Post- operative sensitivity(T0: 1 Week Baseline T1: 6 Months T2: 12 Months)
- Fracture of Restoration(T0: 1 Week Baseline T1: 6 Months T2: 12 Months)
- Bleeding on Probing(T0: 1 Week Baseline T1: 6 Months T2: 12 Months)
研究者
AHMED AYMAN ESMAIL MAHMOUD
Principal investigator
Future University in Egypt