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临床试验/NCT03771196
NCT03771196Unknown不适用

Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2019年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
Change in the clinical performance using United State Public Health Service (USHPS)

研究概览

简要总结

Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer (RMGI) in class V o will be evaluated over 12 months using United State Public Health Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations

详细描述

Recent developments in the province of material sciences, some novel materials require direct association with oral environment for renewal, recharging or enhancing of the constituents of the restoration to improve marginal integrity to decrease bacterial microleakage. Physical and chemical properties of dental restorations have been progressed such that individual components may exert a bioactive role in the prevention, remineralization, and restoration of active carious lesions.Fluoride containing restorative materials recently gained great attention. Fluoride decreases caries activity by being a bacteriostatic and by decreasing the solubility of enamel and dentin through its integration into tooth tissue to form fluoroapatite. Moreover, it aids to remineralize defected tooth structure after demineralization. conventional GICs and RMGICs are have high fluoride release and could be specified clinically to repair decayed non-biting areas in high caries risk patients.To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified GIs (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment.

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)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cervical Class V carious lesions.
  • Age 18-50 years.
  • Co-operative patients approving to participate in the study.
  • Pulp asymptomatic vital carious posterior teeth.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

排除标准

  • Systemic disease or severe medical complications.
  • Allergic history concerning methacrylates
  • Rampant caries
  • Pregnancy
  • Disabilities
  • Heavy smoking; xerostomia
  • Lack of compliance
  • Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

研究组 & 干预措施

Bioactive-Restorative material

Experimental

Activa Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.

干预措施: Bioactive Restorative Material (Other)

Resin Modified Glass Ionomer (RMGI)

Active Comparator

Fuji II Lc, fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics a wear-resistant, self-adhesive, light-cured resin coating.

干预措施: Resin-modified glass ionomer (Other)

结局指标

主要结局

Change in the clinical performance using United State Public Health Service (USHPS)

时间窗: Change from the baseline at 6 months and12 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

Yehia Hafez Yehia

Yehia Hafez Yehia

Cairo University

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