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临床试验/NCT05597956
NCT05597956已完成不适用

Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients

University of Valencia2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Change in the color of opacities

研究概览

简要总结

Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain.

The term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface.

An added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects.

Given the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • . Pediatric patients, aged between 9 and 16 years.
  • Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.
  • Patients who present at least one opacity in the central incisors.
  • Go to the dental clinic for revision or treatment of the University of Valencia.

排除标准

  • Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.

结局指标

主要结局

Change in the color of opacities

时间窗: Between five and six months

Measured in color changes of opacities using the CIE L\*A\*B\* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L\*-axis gives the lightness: a white object has an L\* value of 100 and the L\* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L\*-axis. Chromatic ('real') colors are described by using the two axes in the horizontal plane. The a\*-axis is the green-red axis and the b\*-axis goes from blue (-b\*) to yellow (+b\*).its measurement is possible thanks to the spectrophotometer. Clinical improvement and better visual perception of infiltrated enamel defects

Change in the density of opacities

时间窗: Between five and six months

DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.

次要结局

  • aesthetic change of opacities(Between five and six months)

研究者

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

Montserrat Catalá Pizarro

Associate Professor

University of Valencia

研究点 (2)

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