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临床试验/NCT04365283
NCT04365283Unknown不适用

Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial

Rana Ayman Kamal0 个研究点目标入组 22 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
主要终点
Proximal Contact (modified USPHS criteria)

研究概览

简要总结

ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

详细描述

High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure.

Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (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. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Proximal lesions in posterior premolars and molars and Age 20-40 years

排除标准

  • Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities

结局指标

主要结局

Proximal Contact (modified USPHS criteria)

时间窗: 1 Year

Ordinal(Alfa/Bravo/Charlie)

次要结局

  • Retention(modified USPHS criteria)(1 Year)

研究者

发起方
Rana Ayman Kamal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rana Ayman Kamal

Resident, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Cairo University

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