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临床试验/NCT05181813
NCT05181813已完成不适用

Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp

Mansoura University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Percentage of primary teeth with control necrotic pulp by radiographic examination

研究概览

简要总结

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

详细描述

Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

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
None

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

  • The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
  • Parents signed the consent to participate in the study.
  • Absence of any systemic disease, which would contraindicate pulp therapy.
  • Child didn't have any history of a sensitive reaction to any component of used materials.
  • Present half to two third of tooth root or more
  • Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

排除标准

  • All that does not correspond to inclusion criteria.

结局指标

主要结局

Percentage of primary teeth with control necrotic pulp by radiographic examination

时间窗: Up to 18 months

The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption

Percentage of primary teeth with control necrotic pulp by clinical examination

时间窗: Up to 18 months

The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.

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

Fathi Abdulraqeb Qasem

PhD in Pediatric Dentistry, Pediatric Dentistry Department

Mansoura University

研究点 (2)

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