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临床试验/NCT07264491
NCT07264491招募中不适用

Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial

Karim Ahmed Awadallah Osman1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
marginal adaptation

研究概览

简要总结

Participants will receive high-quality dental restorations, installed and monitored by qualified dental professionals regular periodic follow up recalls will be assigned early detect any consequences free of charge repairs or remakes for any failed dental restorations this research will help in the improvement of the tested materials

详细描述

Direct benefit of the research to the human volunteer:

  • Participants will receive high-quality dental restorations (hybrid ceramic full coverage restorations) fabricated using standardized protocols and materials.
  • All participants will have their restorations placed by qualified dental professionals in a controlled clinical environment, ensuring proper technique and follow-up care.
  • Participants will benefit from regular follow-up examinations at 6, 12, and 18 months, which allows for early detection and management of any potential issues with their restorations.
  • Any issues or failures identified during the follow-up period will be documented and repaired at no additional cost to the participant.
  • Participants will contribute to advancing dental knowledge regarding optimal hybrid ceramic materials, which may lead to improved treatment protocols and long-term outcomes for future dental patients.
  • The research provides an opportunity for comprehensive oral health monitoring beyond just the restoration itself, potentially identifying other dental issues that might require attention.

The scientific interest and the desired public benefit of the research:

Scientific Interest

  1. This research will help understanding the material-specific outcomes in terms of marginal adaptation, color match, retention, surface texture, and restoration failure
  2. The study will contribute to the understanding of the relationship between laboratory findings and clinical outcomes for dental materials, particularly regarding hybrid ceramics.
  3. The findings may generate evidence on the clinical effectiveness and long-term behavior of two hybrid ceramic materials
  4. The research will provide long-term clinical data on modern dental materials, which is valuable for developing future materials and techniques.
  5. The study evaluates how the properties of Beautilink SA self-adhesive resin cement interact with these crown materials to affect clinical outcomes, offering new insights into optimal cementation protocols.

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

Masking Description

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult patients requiring full coverage crowns in aesthetic zone
  • •Age ≥ 21 years
  • •Vital or endodontically treated teeth
  • •Willing and able to provide written informed consent
  • •Ability to attend all follow-up appointments
  • •Adequate oral hygiene as determined by the investigator

排除标准

  • •Patients with active periodontal disease (probing depth > 4mm, bleeding on probing)
  • •Patients with parafunctional habits (e.g., bruxism confirmed by clinical examination)
  • •Poor oral hygiene (plaque index > 30%)
  • •Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
  • •Known allergies to study materials (ceramic materials, or resin cement components)
  • •Inability to comply with study requirements
  • •Current participation in other dental clinical trials

研究组 & 干预措施

Vita Enamic Hybrid Ceramic full coverage Crowns

Active Comparator

Polymer-infiltrated-ceramic-network material (Vita Enamic)

干预措施: Shofu HC Hard full coverage corwns (Other)

Shofu Hard HC full coverage crowns

Experimental

highly esthetic ceramic-based restorative (hybrid ceramics) for milling into dental restorations using a dental CAD/CAM system.

干预措施: Vita Enamic full coverage crowns (Other)

结局指标

主要结局

marginal adaptation

时间窗: from enrollment to the end of treatment at 18 months

measurement of vertical and horizontal discrepancies at the margins of dental restorations

次要结局

  • Color match(from enrollment to the end of treatment at 18 months)

研究者

发起方
Karim Ahmed Awadallah Osman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karim Ahmed Awadallah Osman

Lecturer, Fixed Prosthodontics Department, Faculty of Dentistry, Cairo University

Cairo University

研究点 (1)

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