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临床试验/NCT05425368
NCT05425368Unknown不适用

Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
主要终点
Dentin bridge formation

研究概览

简要总结

Aim of the study:

To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.

详细描述

Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.

Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.

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)

盲法说明

Two blinded (patient, radiographic assessor of results)

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient and parent showing cooperation and compliance.
  • Children 9-14 years old
  • Vital deeply carious young first permanent molar(s) with complete root formation
  • Asymptomatic teeth or without clinical symptoms of spontaneous pain
  • Both genders will be included.

排除标准

  • Children unable to return for recall visits.
  • Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).
  • Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)

研究组 & 干预措施

silver diamine fluoride group

Experimental

partial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling

干预措施: Silver diamine fluoride (Drug)

mineral trioxide aggregate group

Active Comparator

partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling

干预措施: Mineral trioxide aggregate (Drug)

结局指标

主要结局

Dentin bridge formation

时间窗: 6 months

Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination

次要结局

  • Postoperative pain(1 week)
  • Absence of sinus or fistula(6 months)
  • radiographic success(6 months)

研究者

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

Marwa Ahmed Ahmed Zaghloul

Principal Investigator

Cairo University

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