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临床试验/NCT05499494
NCT05499494Unknown不适用

Clinical Evaluation of Bioactive Injectable Resin Composite Versus Conventional Nanohybrid Composite in Posterior Restorations, 18 m Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
Change in the clinical performance

研究概览

简要总结

The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities

详细描述

Statement of the problem:

Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.

The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.

Rationale for carrying out the trial:

The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants:
  • Age range 20-50 years.
  • Males Or females .
  • Co-operative patients approving to participate in the trial.
  • class I or II carious lesions premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

排除标准

  • Participants:
  • Patients with general systemic illness.
  • Allergic history against any component of used material.
  • Disabilities.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of parafunctional habits.
  • Temporomandibular joint disorders.
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth.
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism.
  • Severe periodontal affection.

结局指标

主要结局

Change in the clinical performance

时间窗: From baseline to 18 months

Measured using modified USPHS criteria

次要结局

未报告次要终点

研究者

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

Hazem Mohamed El Deriny

Assistant lecturer at operative dentistry

Cairo University

研究点 (1)

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