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临床试验/NCT04846101
NCT04846101暂停不适用

Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations

University of Jordan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
1
主要终点
Instrumental Color assessment

研究概览

简要总结

One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).

详细描述

In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.

The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.

All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment

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)

盲法说明

Blind Observers will be asked to assess the shade matching capacity of the restorative material on a Likert Scale.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy patients
  • •Patients requiring anterior restorations
  • •Vital teeth
  • •Absence of periodontal or pulpal disease
  • •Patients willing to sign informed consent and returning for follow up

排除标准

  • •Patients with extensive caries and tooth loss
  • •Patient with periodontal disease
  • •Patients with poor oral hygiene and lack of motivation
  • •Patient with severe extrinsic or intrinsic discolorations

研究组 & 干预措施

Anterior restorations using single shade OMNICHROMA composite

Experimental

Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: OMNISHADE (Other)

Anterior restorations using single shade OMNICHROMA composite

Experimental

Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Instrumental Shade Analysis (Diagnostic Test)

Anterior restorations using single shade OMNICHROMA composite

Experimental

Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Visual Shade Analysis (Other)

Anterior restorations using single shade OMNICHROMA composite

Experimental

Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Patient satisfaction (Other)

Anterior restorations using multi-shade composite

Active Comparator

Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: MULTISHADE (Other)

Anterior restorations using multi-shade composite

Active Comparator

Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Instrumental Shade Analysis (Diagnostic Test)

Anterior restorations using multi-shade composite

Active Comparator

Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Visual Shade Analysis (Other)

Anterior restorations using multi-shade composite

Active Comparator

Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement.

干预措施: Patient satisfaction (Other)

结局指标

主要结局

Instrumental Color assessment

时间窗: 2 years

Color difference between restoration \& tooth will be assessed using VITASHADE spectrophotometer

Visual color assessment

时间窗: 2 years

Color difference between restoration \& tooth will be evaluated by independent observers

次要结局

  • Patient satisfaction(2 years)

研究者

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

Susan Hattar

Associate Professor

University of Jordan

研究点 (1)

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