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临床试验/NCT05434884
NCT05434884已完成不适用

Clinical Performance of Two CAD/CAM Fabricated Ceramic Restorations With Different Preparation Designs for Rehabilitation Of Permanent First Molars Affected With Molar Incisor Hypomineralisation (MIH): Clinical Randomized Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年7月10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
64
试验地点
1
主要终点
marginal integrity

研究概览

简要总结

This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (MIH), evaluated at different time periods

详细描述

Clinical evaluation of all restorations will be performed according to:

  • Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.

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, Care Provider)

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient from 8 to 13 years
  • permanent first molar tooth affected with different severity levels of MIH
  • Ability to physically and psychologically tolerate conventional restorative procedures.

排除标准

  • Patients have active periodontal diseases.
  • Patient with poor oral hygiene and motivation.
  • Patient with psychiatric problems or unrealistic expectations

结局指标

主要结局

marginal integrity

时间窗: 6 months

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 6 months after cementation

retention

时间窗: 1 year

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation

colour stability

时间窗: 12 months

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 12 months after cementation

Elimination of sensitivity

时间窗: 3 months

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 3, months after cementation

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

sara nabil

Lecturer of pediatric dentistry

Al-Azhar University

研究点 (1)

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