跳至主要内容
临床试验/NCT06767670
NCT06767670招募中不适用

Evaluation of Oral Hygiene Status in Correlation With Microbial Load in the Oral Cavity Following Restorations of Primary Molars Using Stainless Steel and Bioflex Crowns (Clinical Randomized Trial)

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.

研究概览

简要总结

Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Participants aged between 4 and 8 years.
  • Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique).
  • No history of any antibiotic consumption 2 weeks before the procedure.
  • No history of fluoride application 2 weeks before the procedure.

排除标准

  • Special children with physical disabilities or emotional disturbances.
  • Children are diagnosed with systemic diseases.
  • Grossly destructed teeth with non-restorable crown structure.
  • Primary teeth with shedding or pathological tooth mobility.

结局指标

主要结局

The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.

时间窗: one months

Collecting the plaque samples from the gingival crevices, buccal mucosa, and occlusal surfaces of the teeth treated using sterile cotton swabs initially and from the respective crown surfaces. After collecting the samples, they will be inoculated onto a plate of Mitis salivarius-bacitracin agar (MSBA), a selective growth medium for cultivating S. mutans.

次要结局

  • Gingival health(one months)
  • Plaque Index (PI)(one month)

研究者

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

Alaa M Eldehna

assistant proffesor

Al-Azhar University

研究点 (2)

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