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临床试验/NCT06195449
NCT06195449已完成不适用

Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement in Restoration of Primary Molars: Randomized Clinical Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
recurrent caries of the tooth

研究概览

简要总结

To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.

详细描述

Restorations replacements are mostly caused by the existence of caries lesions surrounding the restorations, which are commonly referred to as secondary caries .

Secondary or recurrent caries is characterized as "lesions that occur at the edges of previously placed dental restorations" or "caries that develop in association with dental restorations or sealants" (CARS).Proper seal at the tooth surface restoration interface is essential . That's why the most frequently material used is (GIC) with the advantage of chemical adhesion to tooth structure, superior esthetics, and long-term fluoride release providing cariostatic effect, but it has the disadvantage of slow setting rate, low fracture toughness, susceptibility to moisture contamination, dehydration during initial phase of setting, and poor wear resistance.

Resin Modified Glass Ionomer and Composite have always been the preferred material for restoration although several modifications have been made recently to improve its properties, Cent ion N is one of the recent ones.

Cent ion N is a tooth-colored basic filling material for direct restoration. It belongs to the material of Alka sites, with high flexural strength. It also has calcium and fluoride releasing properties comparable to conventional GIC, besides it is quick and easy to use.

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
Double (Participant, Outcomes Assessor)

盲法说明

Statistician

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children having carious primary molars without pulp exposure and normal radiograph.
  • •Children between age 5 and 7 years.
  • •Both male and female are included.
  • •Cooperative Children.

排除标准

  • •Patients with systemic diseases.
  • •Parent refuse to participate.

研究组 & 干预措施

Alkasite restorative material in primary molar

Experimental

ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)

干预措施: ALKASITE RESTORATIVE MATERIAL (Other)

Glass Ionomer Cement in primary molar

Active Comparator

ARM2: Glass Ionomer Cement(CONTROL)

干预措施: Glass Ionomer Cement (Other)

结局指标

主要结局

recurrent caries of the tooth

时间窗: 12 months

Radiograph \&Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS

次要结局

  • Anatomic Form of the tooth(12 months)
  • Color match of the restoration(12 months)
  • Marginal Adaptation of the tooth(12 months)
  • Marginal Discoloration of the tooth(12 months)

研究者

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

Ola Yasir Abdulaziz Mahmoud

principal investigator

Cairo University

研究点 (1)

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