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临床试验/NCT06721741
NCT06721741尚未招募不适用

Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique:A Randomized Clinical Study

Cairo University0 个研究点目标入组 36 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
36
主要终点
Patient relevant criteria

研究概览

简要总结

This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.

详细描述

Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable

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
否

入选标准

  • •Clinical Criteria:
  • •Children from age 4-
  • •Cooperative children and willing for follow-up visits.
  • •Mandibular second Primary molars with multi-surface caries
  • •Radiographic criteria:
  • •Mandibular second Primary molars with at least two-thirds of the root remaining.

排除标准

  • •• General Criteria:
  • •Unable to attend follow-up visits
  • •Refuse to participate in the study
  • •Uncooperative child
  • •Clinical Criteria:
  • •Tooth with grade II or grade III mobility
  • •Children with bruxism
  • •Pulpally involved teeth
  • •Radiographic Criteria:
  • •Tooth with pathological root resorption
  • •Teeth with root caries

研究组 & 干预措施

Stainless steel crown

Active Comparator

Control group

干预措施: Stainless steel crowns (Other)

Bioflex crown

Experimental

Intervention group

干预措施: Nusmile bioflex crowns (Other)

结局指标

主要结局

Patient relevant criteria

时间窗: 1 Year

1. Clinically Success if: No clinical signs or symptoms like: * Pain * Dental Abscess/Swelling * Sinus Tract/ Fistula * Mobility 2. Radiographically Success if: No pathology visible on x-ray like: * Internal/External Root Resorption * Peri-radicular Radiolucency * Furcation Involvement * Periapical Pathosis

次要结局

  • Crown Relevant Criteria(1Year)

研究者

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

hajer ahmed mousa mohamed

Principal investigator

Cairo University

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