跳至主要内容
临床试验/NCT07355920
NCT07355920进行中(未招募)不适用

Clinical Evaluation of Alkasite Composite as a Final Restoration for Pulpotomized Primary Molars.

Tanta University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年8月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
1
主要终点
Clinical evaluation of the final restoration according to USPHS Criteria

研究概览

简要总结

The aim of this study will be directed to:

Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized 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
Other
盲法
Single (Outcomes Assessor)

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

  • Deep carious vital primary molars at site 1, 2, and size 3 according to the SI/STA classification of caries.
  • Healthy children free from systemic diseases.
  • Cooperative patient: Frankel rating 3,
  • Radiographically:
  • Deep caries approximating the pulp.
  • Roots with no more than one-third physiologic resorption.
  • Normal lamina dura and periodontal ligament space.

排除标准

  • Patients with bruxism.
  • Clinical signs or symptoms of irreversible pulpitis or pulp degeneration.
  • Parents refuse treatment.
  • Radiographically:
  • Furcation involvement.
  • periapical lesion.
  • Pathologic resorption (internal or external).

研究组 & 干预措施

Group I: Study group :Alkasite( cention forte )

Experimental

25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.

干预措施: Cention Forte (Procedure)

Group II :Control group: Tetric N-Ceram

Active Comparator

25 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.

干预措施: Tetric® N-Ceram (Procedure)

结局指标

主要结局

Clinical evaluation of the final restoration according to USPHS Criteria

时间窗: at 3, 6, and 9 months

Clinical evaluation of the final restoration is done according to the modified united states public health service USPHS Criteria for direct clinical evaluation of restoration

次要结局

未报告次要终点

研究者

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

Manar Taha Mokhtar Hamed Elsayed

Principal Investigator

Tanta University

研究点 (1)

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