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临床试验/NCT06185881
NCT06185881已完成不适用

Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

Cairo University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1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
80
试验地点
2
主要终点
Change in Marginal integrity score

研究概览

简要总结

This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and both assessors will be blind to the type of material used

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with untreated cervical carious lesions
  • Patients with normal occlusion
  • Vital teeth with carious cervical lesion with asymptomatic vital pulp.
  • Teeth with no or minimum mobility.
  • Teeth with normal occlusion.
  • Teeth with surrounding healthy gingiva and supporting-structures.

排除标准

  • Patients who are unable to return for recall appointments
  • Presence of abnormal oral, medical or mental conditions.
  • Patients with severe medical diseases.
  • Patients with xerostomia
  • Patients with parafunctional habits.
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Severe periodontal problems.
  • Non carious cervical lesions.

结局指标

主要结局

Change in Marginal integrity score

时间窗: [Time Frame: Baseline, 6 months, 12 months]

Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

次要结局

  • Change in Secondary caries scores([Time Frame: Baseline, 6 months, 12 months])
  • Change in Marginal discoloration, Color match, Gross fracture scores([Time Frame: Baseline, 6 months, 12 months])
  • Change in Post operative Hypersensitivity([Time Frame: Baseline, 7 days, 6 months])

研究者

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

Rawda Hesham Abd ElAziz

Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Cairo University

研究点 (2)

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