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临床试验/NCT06933927
NCT06933927尚未招募不适用

Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
28
试验地点
1
主要终点
Gingival Health

研究概览

简要总结

The goal of this clinical trial is to evaluate the Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question[s] it aims to answer is there are the differences in bacterial adhesion and gingival health between bioflx and zirconia crowns The study will also assess the clinical performance of both types of crowns in terms of bacterial adhesion , child and parents satisfaction,as well as preparation time.

详细描述

Dental caries is an oral disease most ubiquitous among children, characterized by a series of demineralization and remineralization cycles. If left untreated, it can progress to cavitated lesions. Usually, the familiar method of managing multi-surface carious lesions in primary teeth with stainless steel crowns .Streptococcus mutans is considered to be the main colonizer and primary etiological factor in caries progression as it stimulates the production of glucans from the food substrates. Research has indicated that S. mutans can be isolated from plaque samples. Consequently the long-term success of a restored tooth is significantly affected by the adhesion of S. mutans to the preformed crowns.Bacterial adhesion on zirconia are sparse. An in vitro study reported the initial bacterial adhesion on the surface of zirconia to be less compared with resins. When a primary tooth is restored with a full-coverage restoration, it establishes a fresh environment conducive to microbial adhesion. Bioflx Crowns the first flexible, durable, and esthetic preformedcrown for primary molars .BFCs are monochromatic, metal-free, tooth-colored crowns used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are similar to SSC in tooth preparation. Additionally, they offer a cost benefit compared to zircon crowns,

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
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged 4-8 years.
  • •decayed in primary molars require full-coverage crowns.
  • •No history of systemic diseases affecting oral health.
  • •Cooperative children.

排除标准

  • •patients with severe medical conditions, badly decayed in primary molars and trauma.

研究组 & 干预措施

Bioflex crowns

Experimental

Bioflx Crowns (BFCs) the first flexible, durable, and esthetic preformedcrown for primary molars .BFCs are monochromatic, metal-free, tooth-colored crowns used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are similar to SSC in tooth preparation. Additionally, they offer a cost benefit compared to zircon crowns

干预措施: (Group A: Bioflx crowns) (Other)

Zirconia crowns

Experimental

zirconia crowns are frequently chosen as a comparator due to their established clinical performance and favorable biological properties. Studies have demonstrated that zirconia crowns exhibit lower bacterial adhesion, particularly of Streptococcus mutans, compared to stainless steel crowns (SSCs). highly polished and smooth surface of zirconia, which minimizes plaque accumulation and subsequent gingival inflammation.

干预措施: (Group B) : Preformed Zirconia crown (Other)

结局指标

主要结局

Gingival Health

时间窗: 6 months

plaque index using Silness\& Löe plaque index:0 - 3 0: no plaque.1: film at gingival margin.2: moderate accumulation.3: abundance of plaque.

Gingival health

时间窗: 6 months

Gingival index using Löe\& Silness :0 - 3 0: healthy gum.1: mild discoloration and edematous gingiva, no bleeding on probing.2: red oedematous and shiny gingiva,bleeding on probing.3: red oedematous and ulceration gingiva, spontaneous bleeding.

次要结局

  • Bacterial adhesion(2 weeks)
  • child and parental satisfaction(6 months)
  • Preparation time(6 months)

研究者

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

Salma Ahmed Abdelrazig Mohammed

principal investigator

Cairo University

研究点 (1)

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