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临床试验/NCT06603116
NCT06603116已完成不适用

Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness

Faculty of Dental Medicine for Girls1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
evaluation of restorations of class two cavities

研究概览

简要总结

Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer

详细描述

  • Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.
  • The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.
  • Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months.

data collected and statistically analyzed

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 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •• Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.
  • •Adjacent and opposing natural teeth should be present.
  • •Patient should be willing to return for follow-up examination and evaluation.

排除标准

  • •• Patient with poor oral hygiene and motivation.
  • •Patient with unrealistic expectations.
  • •Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.

研究组 & 干预措施

Bioactive Giomer restoration.

Experimental

material applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds

干预措施: treatment of class two cavities (Other)

Nano-hybrid Composite restoration.

Active Comparator

applied to the cavity use the conventional incremental technique according to manufacturer instruction

干预措施: treatment of class two cavities (Other)

结局指标

主要结局

evaluation of restorations of class two cavities

时间窗: from one week to one year

Measured used FDI criteria

次要结局

未报告次要终点

研究者

发起方
Faculty of Dental Medicine for Girls
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Noha Taher

Assistant lecturer at operative department

Faculty of Dental Medicine for Girls

研究点 (1)

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