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临床试验/NCT04960852
NCT04960852已完成不适用

Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite: A Single Arm Clinical Trial

National Research Centre, Egypt2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
shade matching (digital analysis)

研究概览

简要总结

Matching the color of resin composite utilized in anterior teeth is believed to be one of the most challenging tasks a dentist has to face in daily practice. The color of the teeth is primary influenced by dentin; on the other hand, enamel has a major influence on the color perception in terms of lightness. In the layering concept, the missing dental tissues are substituted in increments with resin composite of the exact shade as the dental tissue. A translucent composite resin is applied over a more opaque composite resin to achieve a depth perception similar to that of the natural teeth. Which indicates that the visible color is the consequence of diffuse reflectance from the internal dentin or opaque material layer through the external translucent layer.

There are numerous elements that make the color matching problematic. These problems arise from the point that color matching rely on many different chromatic properties related to the teeth and resin composite; those include hue, chroma and value; translucency, opalescence and fluorescence; light diffusion and transmission; and luster and texture of the surface. To reach the ideal esthetics, restorative material should mimic the natural tooth in the previously mentioned properties, in addition of having a long time color stability.

Massive efforts were achieved over the years to improve the esthetic properties of dental resin composite restorative materials. Recently, a single shade structurally colored universal composite (Omnichroma, Tokuyama Dental) intended for use with most direct restorative clinical cases was introduced in the market. Its manufacturer claimed that it exhibits color change toward the color of the surrounding hard dental tissues. Thus, it has the advantages of improving the esthetic appearance of the restoration, decrease dependence on shade-matching procedures, decrease the number of shade guide tabs, and counteract for color mismatches to some degree.

Up till now no studies assessed the color match of Omnichroma resin composite in anterior teeth cavities clinically. Thus, the aim of this clinical trial was to investigate if the single shade structurally colored universal resin composite (OMNICHROMA) will modify its shade to match the tooth structure shade in anterior teeth cavities.

详细描述

Participants' recruitment:

The patients will be selected from outpatient clinic of National Research Centre (NRC), Cairo; Egypt Eligible patients who agreed to participate in this trial will sign on written informed consents.

Clinical procedure

  • Teeth color measurement Each patient first will receive scaling and polishing procedures to clean the teeth surfaces. A total of 45 anterior teeth cavities will be prepared. Before cavity preparation, shade determination will be performed with Vita Easyshade spectrophotometer. The probe tip will be positioned perpendicular and flushed onto the buccal surface of the tooth to get correct measurements.
  • Cavities preparation Appropriate local dental anesthesia (Mepecaine-L) 1mg will be injected preoperatively unless declined by the patient. Treated teeth will be properly isolated and saliva ejector will be utilized.

Conservative cavities will be prepared with #330 carbide bur (FG, Dentsply Midwest®) fixed to a high speed hand piece with water coolant system. Cavity preparation will be limited to the removal of caries and the exact cavity form and size will be obtained after caries removal. Each bur will be discarded after 5 preparations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with carious class V or Class III cavities
  • Young adult Males or female
  • patient with low or moderate caries risk index
  • Co-operative patients approving to participate in the study

排除标准

  • Patients with a compromised medical history
  • Severe or active periodontal disease
  • Severe medical complications
  • Erosive lesions
  • Lack of compliance and rampant caries

结局指标

主要结局

shade matching (digital analysis)

时间窗: after 1 week of restorations placement

to assess the shade matching of the newly introduced OMNICHROMA resin composite to the tooth structure. Image analysis will be carried out by comparing LAB values using Easyshade spectrophotometer

次要结局

  • shade match acceptance (visual assessment)(after 1 week of restorations placement)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaymaa Mohamed Nagi

Assisstant professor in restorative and dental materials department

National Research Centre, Egypt

研究点 (2)

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