此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Evaluation of SHOFU FX-LC RMGI Restoration Versus FUJI II RGMI in Management of Anterior Carious Cervical Lesions

2026年11月8日 更新者：Salma Hany Mohamed Saeed、Cairo University

Clinical Evaluation of Acrylamide Based RMGI Restoration Versus Conventional Resin Modified Glass Ionomer in Management of Patients Having Anterior Carious Cervical Lesions: A Randomized Clinical Trial.

The development of resin-modified glass ionomers (RMGIs) represents a strategic evolution designed to augment the mechanical performance of conventional glass ionomers. By incorporating a resin matrix, these materials achieve notable physical improvements, including superior fracture toughness, increased resistance to occlusal wear, and higher resilience to moisture degradation, alongside the clinical advantage of a prolonged working time. (Hübel 2003)However, an excessive proportion of hydrophobic multifunctional monomers within the RMGI matrix suppresses the essential aqueous acid-base reaction.

To overcome conventional resin modified glass ionomer drawbacks, FX-LC tried to overcome it by incorporating a new multifunctional acrylamide monomer called New Generation Acrylamide monomer (NGA monomer) with which they claim that it exhibits high water solubility due to its four amide bonds (-CO-NH-) and demonstrates high polymerization reactivity, even in the presence of water. It has unique properties that are not found in conventional multifunctional monomers

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient inclusion:

    1. Adult Patients age >18 years.
    2. Males or Females
    3. Patients with good likelihood of recall availability.

Tooth inclusion:

  1. Permanent anterior teeth with cervical Class V, carious lesions (ICDAS 3-5)
  2. Vital and with positive reaction to cold stimulus.
  3. Well-formed and fully erupted teeth.

Exclusion Criteria:

  • Patient exclusion:

    1. Participants with general/systemic illness.
    2. Pregnant or lactating females.
    3. Concomitant participation in another research study.
    4. Inability to comply with study procedures.
    5. Heavy Bruxism Habits.
    6. Last experience with allergic reactions against any components of the used materials.
    7. Patients receiving orthodontic treatment.

Tooth exclusion:

  1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  2. Non-vital teeth, Fractured or cracked teeth.
  3. Secondary carious lesions.
  4. Hypocalcified or hypoplastic teeth

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：SHOFU FX-LC RMGI

After rubber dam isolation, the prepared cavities will be conditioned using Dentin conditioner (GlasIonomer FX-LC Conditioner, Japan) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (SHOFU FX- LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds.

The mixture then is extruded directly out of capsule into prepared cavities with a capsule gun ensuring that no air bubbles will be included.
其他：SHOFU GlasIonomer FX-LC

FX-LC is RMGI which incorporates New Generation Acrylamide monomer, After rubber dam isolation, the prepared cavities will be conditioned using Dentin conditioner (GlasIonomer FX-LC Conditioner, Japan) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (SHOFU FX- LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds.

The mixture then is extruded directly out of capsule into prepared cavities with a capsule gun ensuring that no air bubbles will be included.

Light curing unit will be used to cure the material for 10 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.
有源比较器：FUJI II RMGI

Cavities will be conditioned using using Dentin conditioner (GC Dentine ConditionerS) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (Fuji II LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds. The mixture then is extruded directly out of capsule into prepared cavity with a capsule gun ensuring that no air bubbles will be included.

light curing unit will be used to cure the material for 20 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.
其他：FUJI II RMGI

FUJI II, Conventional resin modifies glass ionomer will bwe applied. Cavities will be conditioned using using Dentin conditioner (GC Dentine ConditionerS) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (Fuji II LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds. The mixture then is extruded directly out of capsule into prepared cavity with a capsule gun ensuring that no air bubbles will be included.

light curing unit will be used to cure the material for 20 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
大体时间：Time Frame: Baseline, 6 months, 12 months, 18 months.
Time Frame: Baseline, 6 months, 12 months, 18 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年11月8日

首先提交符合 QC 标准的

2026年11月8日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月8日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 22051999

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅