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临床试验/NCT07049016
NCT07049016已完成不适用

Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid Composite of Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial

October University for Modern Sciences and Arts2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Aesthetic Clinical success

研究概览

简要总结

Molar Incisor Hypomineralization (MIH) is enamel hypomineralization defined as qualitative defects caused by disruptions in either the calcification or maturation phases of amelogenesis affecting one or more first permanent molars (FPMs) and permanent incisors.

详细描述

Conventional treatment for such defects necessitates additional removal of the complete tooth structure to receive full crowns that cause more biologically harmful consequences like postoperative hypersensitivity and aggressive tooth structure loss. To fulfill the biological criteria for tooth preparation, conservatism is the major notion and goal that prosthodontists strive to achieve. Nowadays, minimally invasive techniques are frequently employed to support this idea. To meet the growing need for conservative and attractive tooth restorations, overlay ceramic restorations (covering all cusps) are becoming more necessary. These restorations show satisfactory mechanics, restoring function, and esthetic with preserving tooth structure Since all materials used to treat such cases, have distinct chemical compositions, they have different properties that affect their clinical outcome. Therefore, it is essential to compare them clinically because any restoration's clinical outcome affects its long-term success. According to the null hypothesis, different materials would not significantly affect the clinical result of ceramic overlay restorations.

Patients in all groups will receive a minimally invasive restoration with high esthetic advantages (Protection of the weak cusps and elimination of carious lesions with an esthetic way out) and long-term success of their MIH affected young permanent molars (either IPS e.max CAD, Direct nanohybrid flowable composite or VITA Suprinity PC-Glass ceramic (zirconia) that require minimal preparation depends on the type of restoration will receive.

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
Single (Participant)

入排标准

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

入选标准

  • 8-18 years old
  • Cooperative children with large carious First Permanent Molars (FPM) lesions associated with weak cusps and defected hypo-mineralized enamel.
  • Controlled dental disease - no active caries or periodontal diseases
  • Patients will be available to be clinically reviewed up to 1 year

排除标准

  • Patients with Symptoms of pulpitis.
  • Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
  • Poor oral hygiene and motivation.
  • Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
  • Patients with debilitating illnesses or complicating medical conditions

结局指标

主要结局

Aesthetic Clinical success

时间窗: 12 months (baseline ''1 day '', 6 and 12 months)

According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

Functional Clinical success

时间窗: 12 months (baseline ''1 day '', 6 and 12 months)

According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

Biological clinical success

时间窗: 12 months (baseline ''1 day '', 6 and 12 months)

According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

次要结局

未报告次要终点

研究者

发起方
October University for Modern Sciences and Arts
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Ahmed Salmoon

Principal investigator

October University for Modern Sciences and Arts

研究点 (2)

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