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临床试验/NCT06461364
NCT06461364已完成不适用

Evaluation of Cuspal Deflection and Fracture Resistance of Different Bulk-fill Restorations and Their Clinical Performance in Class II Cavities

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月20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
30
试验地点
1
主要终点
FDI criteria Esthetic

研究概览

简要总结

Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics. These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries, crown fractures, tooth wear, and congenital defects.

详细描述

It has been reported that the polymerization shrinkage and its associated contraction stress are the greatest limitation in the use of resin-based composite (RBC) as a restorative material for posterior teeth.

Shrinkage stress that is generated due to the polymerization reaction is known as a multifaceted complicated condition. There are many factors aiding to development of the rate of shrinkage stress such as material formulation, degree of conversion, polymerization kinetics, flow capacity in the early stages of the curing reaction, and elastic modulus of the material itself.

Shrinkage stress appear in the form of several manifestations as cuspal movement which can result in enamel micro cracks, cervical marginal gaps, creating postoperative sensitivity, discoloration of the margins, recurrent caries, breakages of the restoration and finally replacement of composite restorations.

New types of restorative materials called bulk-fill restorative materials have been introduced to reduce time required for placement. These materials can be placed in bulk layer up to 4-5mm with adequate polymerization and low polymerization shrinkage stress. However, little information is available regarding the effect of these restorative materials on cuspal deflection.

The first thermoviscous bulk-fill composite, has the viscosity of a flowable composite and the sculptability of a packable composite all in a single material. Prior to placement, this material is warmed in a modified caps warmer. Bulk-fil composite satisfies the sealing of the proximal box as well as attains the desired anatomy in a single bulk-cure product in class II restorations.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included in the study must be with at least two proximal caries teeth of ICDAS score
  • Patients with moderate and high caries risk index.
  • Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures.
  • At least two permanent molars at one side requiring class ii caries lesions, with at least one neighboring tooth and in occlusion with antagonistic teeth.
  • Moderate to large size cavities that extended into dentine, while maintain natural tooth contour.
  • Absence of tooth mobility, tenderness, severe pain or pre-operative sensitivity.
  • Normal occlusion relation with normal dentition

排除标准

  • Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
  • Developmental disorders and adjacent soft tissue lesions.
  • Patients with systemic illness will be excluded

结局指标

主要结局

FDI criteria Esthetic

时间窗: from 3 months to 12 months

evaluated surface luster and surface staining

FDI criteria Biological

时间窗: from 3 months to 12 months

Biological evaluated post operative hypersensitivity and recurrence caries

FDI criteria Functional

时间窗: from 3 months to 12 months

evaluated fracture of material and retention,occlusal contour and wear

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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