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临床试验/NCT06396195
NCT06396195尚未招募不适用

Comparative Evaluation of Clinical Success,Parental and Child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars: A Randomized Clinical Study

Cairo University0 个研究点目标入组 28 人开始时间: 2024年8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
28
主要终点
crown retention

研究概览

简要总结

Comparative Evaluation of Clinical Success,Parental and child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars: A Randomized Clinical Study

详细描述

In the field of pediatric dentistry, various materials can be utilized to treat decayed primary teeth, such as composites, glass ionomer cements, or steel crowns. Despite demonstrating acceptable properties, numerous failures are consistently documented, predominantly linked to issues like secondary caries.

Over the course of time, a variety of full-coverage dental restorations have been introduced and integrated into pediatric dental care. Stainless-steel crowns (SSCs) have emerged as the most widely accepted and frequently utilized full-coverage restoration for both primary and permanent teeth in children. Since the 1950s, pediatric dentists globally have favored SSCs due to their exceptional durability, secure cervical fit, cost-effectiveness, and the fact that they require minimal technique sensitivity during the restoration process.

Stainless steel crowns (SSCs) offer robust and dependable full-coverage restorations, remaining in place throughout the lifespan of a primary tooth. However, a notable drawback is the unfavorable metallic appearance, which is disliked by both parents and children. Numerous efforts have been made to develop alternative esthetic substitutes for SSCs, such as composite, polycarbonate, thermoformed plastic, and zirconia.

As the emphasis on esthetics in children has grown, technological progress has successfully brought about the introduction of prefabricated zirconia crowns (ZCs). The adoption of zirconia crowns for primary dentition began in 2008. While zirconia crowns share mechanical properties with metal, they necessitate greater tooth reduction.

The Bioflx crowns are characterized by their flexibility, durability, and adaptability. These crowns are preformed pediatric crowns designed for aesthetics, combining properties found in both stainless steel and zirconia crowns. However, there is a notable absence of scholarly evidence evaluating the properties of Bioflx crowns and their impact on clinical outcomes and parental satisfaction when compared to conventional options. Consequently, this study aims to examine the clinical performance of Bioflx crowns and traditional stainless steel crowns (SSCs) in pediatric patients, with a focus on assessing child and parental satisfaction.

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
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Uncooperative child .
  • Handicapped children either mentally or physically.
  • Inability to attend follow-up visits.
  • Refuse to participate in the study .
  • Tooth with poor prognosis (unrestorable).
  • Teeth with root caries .
  • Primary teeth with more than half of the root resorbed or presence of periapical pathology seen in the radiograph .

结局指标

主要结局

crown retention

时间窗: 12 months

by tactile examination crown retention scoring (intact or chipped )

parental satisfaction

时间窗: 12 months

by a questionnaire-based five-point rating Likert's scale. from (1-5 ) 1= unsatisfied at all to 5 = very satisfied

次要结局

  • marginal integrity(12 months)
  • gingival health(12 months)
  • patient satisfaction(12 months)
  • oral hygiene(12 months)

研究者

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

Hajar Ashraf

Dr. Hajar Ashraf

Cairo University

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