跳至主要内容
临床试验/NCT06597669
NCT06597669招募中不适用

Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

Hue University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月4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
100
试验地点
2
主要终点
Failure of stainless steel crowns

研究概览

简要总结

Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars

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, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
  • Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

排除标准

  • Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
  • Children are allergic to nickel and resin.
  • Children unable to return for recall visits.
  • Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
  • Children are undergoing orthodontic treatment with fixed or removable appliances.

结局指标

主要结局

Failure of stainless steel crowns

时间窗: 12 months

Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.

次要结局

  • Occlusal contact(12 months)
  • Periodontal health(12 months)

研究者

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

Le Van Nhat Thang

Lecturer

Hue University of Medicine and Pharmacy

研究点 (2)

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