Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 主要终点
- Restoration success based on FDI criteria (clinical and radiographic evaluation)
研究概览
简要总结
This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits
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)
盲法说明
Outcome assessment was performed by a blinded assessor who was unaware of group allocation; operator blinding was not feasible due to differences in material handling.
入排标准
- 年龄范围
- 4 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-8 years old.
- •Primary molars indicated for restorative treatment.
- •No pulp involvement or history of dental pain.
- •Cooperative children (Frankl: +ve or ++ve).
排除标准
- •Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
- •Severe developmental enamel defects or insufficient enamel for bonding.
结局指标
主要结局
Restoration success based on FDI criteria (clinical and radiographic evaluation)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Hosam Hassan
principal investigator
Al-Azhar University
