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临床试验/NCT04363996
NCT04363996Unknown不适用

Clinical Evaluation of New Bioactive Restorative Material Versus Resin Modified Glass Ionomer in Restoration of Cervical Lesions: Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Surface texture

研究概览

简要总结

Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent).

详细描述

The resin composites used with bonding agents are popularly used for the restoration of cervical lesions. These materials exhibit high strength and physical properties as well as good esthetic property but they don't offer the chemical bonding and fluoride release potentials necessary for managing high caries risk patients (Khoroushi et al., 2012).

Fluorides containing restorative materials have been advocated as the material of choice for restoring cervical lesions in high caries risk patients since this kind of material offers chemical bonding, fluoride release, and caries inhibiting potentials. Conventional Glass Ionomer and Resin modified glass ionomer restorative materials have high fluoride release and could be specified clinically to repair cervical lesions in high caries risk patients. However, clinical acceptance of these materials has been limited because of their low tensile strength, brittleness, and low resistance to wear (Somani et al., 2016).

Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent). Activa Presto light-cured material from Pulpdent is the company's newest product that features biomimicry as Activa Bioactive dual-cured material. It is available in a 1.2 mL syringe for easy application, and no longer need for a special dispensing gun to apply the material. Consequently, placement of the resin is precise and highly adaptive to the cavity margins. It is highly radiopaque (250%), so it can be easily followed on radiographs.

There are eight esthetic shades: A1, A2, A3, A3.5, B1, BW and two new darker cervical shades A4 and A6 which can be useful in geriatric patients. 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 (ACTIVA Presto - Pulpdent).

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, Investigator, Outcomes Assessor)

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

  • Cervical carious lesions anterior teeth and premolars.
  • Age 20-40 years.

排除标准

  • Rampant caries.
  • Disabilities.
  • Oral Dryness.

结局指标

主要结局

Surface texture

时间窗: 1 year

ordinal

次要结局

  • Marginal adaptation(1 year)

研究者

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

Amera Nabel

Principal Investigator

Cairo University

研究点 (2)

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