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临床试验/NCT07689032
NCT07689032尚未招募不适用

Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth: A 24-Month Randomized Clinical Trial

Cairo University0 个研究点目标入组 24 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Annual wear rate

研究概览

简要总结

This randomized clinical trial aims to to evaluate and compare the 24-month surface wear of the restoration and the surface wear of the opposing natural tooth structure of CAD/CAM Hybrid Ceramic (SHOFU Hard blocks) versus Resin-based Composite (BRILLIANT Crios) overlays, utilizing a digital subtraction methodology (Intraoral Scanner and Geometrical Subtraction Software) in endodontically treated molar teeth.

详细描述

The rationale for this 24-month RCT is driven by the need for high-level, evidence-based data to guide clinical material selection for compromised teeth. This trial is designed to directly compare two materials specifically engineered to be stress-absorbing in the oral environment. The primary intervention, the SHOFU Restorative System (Hard blocks), is a Hybrid Ceramic engineered to combine the durability of ceramics with the elasticity of polymers. Its reduced hardness and dentin-like modulus allow for rapid machining and are associated with reduced antagonist abrasion compared to conventional ceramics. The second material, serving as the comparator, is the Coltène Restorative System (BRILLIANT Crios), which is a reinforced nano-hybrid composite characterized by an elastic modulus comparable to dentin, designed for optimal shock absorption and confirmed to be gentle on antagonist teeth.

Focusing the study on endodontically treated molars addresses a highly prevalent clinical scenario where maximizing the longevity of the restoration and the remaining tooth structure is paramount. The use of a full-cusp-coverage overlay design represents the maximum conservation approach for these compromised teeth while ensuring that the selected restorative materials do not exert harmful effects on opposing dentition.

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 (Outcomes Assessor)

入排标准

年龄范围
22 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 22 and 45 years.
  • Low to moderate caries risk.
  • Normal occlusion.
  • Absence of signs or symptoms of temporomandibular joint (TMJ) disorders.
  • Satisfactory oral hygiene.
  • Medically fit to receive routine restorative dental treatment.
  • Permanent molars.
  • Asymptomatic endodontically treated teeth.
  • Homogeneous root canal fillings extending 1-2 mm from the radiographic apex.
  • Compound cavities.
  • Favorable occlusion.
  • Presence of both an adjacent tooth and a sound opposing tooth in occlusion

排除标准

  • * Presence of bruxism.
  • Poor patient cooperation.
  • Inability or unwillingness to attend follow-up appointments.
  • Anticipated travel during the study period.
  • Poor oral hygiene.
  • Chronic or advanced periodontitis.
  • Known allergies to any of the materials used in the study.
  • Patients who are pregnant or breastfeeding.
  • Teeth with <1" mm" of residual wall thickness.
  • Deep subgingival cavity margins.
  • Severe periodontal problems.
  • Radiographic signs of apical pathology.

结局指标

主要结局

Annual wear rate

时间窗: 24 months

Digital Scanner +Geometrical Subtraction Software

次要结局

  • Functional properties, Biological properties and Esthetic properties(24 months)

研究者

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

Sara Salem Sayed Ahmed

PhD Candidate

Cairo University

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