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临床试验/NCT07097688
NCT07097688进行中(未招募)1 期

Regenerative Endodontic Treatment Using Sodium Hexametaphosphate (SHMP) For Necrotic Immature Permanent Anterior Teeth: In Vivo And In Vitro Study

Ahmad Elheeny1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月29日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test

研究概览

简要总结

evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial

详细描述

7 to 11 years old will be selected with no sex predilection for the study from out patients of Pediatric and Community Dentistry Department, Minia University, according to the following eligibility criteria and evaluate clinically and radiographically regenerative potential of sodium hexametaphosphate (SHMP) on stem cells from the apical papilla for 18-month randomized controlled trial

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 (Investigator)

盲法说明

-Included patients will be randomized into one of the study groups. Randomization will be performed using a computer-generated block randomization system (Microsoft office excel, 2007).

Concealment, A plan of management will be sealed in closed envelops, numbered according to the randomization tables.

Packing, sealing and numbering will all be performed by a neutral health care provider other than the investigator.

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Presence of necrotic anterior immature teeth. Parents accepting the treatment modality.History, clinical and radiographic examination reveals absence of pulp vitality Patient abruptly health

排除标准

  • Tooth mobility. Children who will not comply to recall program. Teeth with history of recurrent periapical pathosis. Hypersensitivity to any material used.

研究组 & 干预措施

Sodium Hexametaphosphate

Active Comparator

dental material

干预措施: Sodium Hexametaphosphate (SHMP) Inorganic polyphosphates (poly[P]) are linear polymers of orthophosphate (Pi) residues linked by energy-rich phosphoranhydride bonds, Ithas multiple physiological funct (Biological)

结局指标

主要结局

Normal responses to percussion, palpation, and normal pocket probing depths, and a positive response to pulp test

时间窗: one year

pulp sensibility test

Absence of signs and symptoms of pain, absence of mobility or periapical lesion

时间窗: one year

PALS scale

次要结局

未报告次要终点

研究者

发起方
Ahmad Elheeny
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmad Elheeny

Assistant professor of Pediatric and Community Dentistry, Faculty of Dentistry, Minia University

Minia University

研究点 (1)

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