跳至主要内容
临床试验/NCT07504393
NCT07504393尚未招募不适用

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

Al-Azhar University0 个研究点目标入组 92 人开始时间: 2026年4月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hosam Hassan

principal investigator

Al-Azhar University

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