此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy

2026年6月28日 更新者：Rania Fathy Mohammed Mohammed、Cairo University

Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)

Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Healthy Cooperative children.
  2. Children between the ages of four and eight years.
  3. Restorable teeth with irreversible pulpitis.
  4. Continuous bleeding after amputation of coronal pulp tissue.

Exclusion Criteria:

  1. Molars that exhibit physiologic root resorption in excess of one-third.
  2. Internal and external root resorption.
  3. Presence of dental abscess, sinus tract or excessive mobility.
  4. Acute spreading infection/cellulitis not manageable with local treatment.
  5. Large periapical/furcation lesion with poor prognosis.
  6. Teeth close to natural exfoliation.
  7. Children with known allergies to study materials or medications used.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Pediatric NiTi rotary files manufactured with AF-H Wire technology
Pediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures
设备：Pediatric NiTi rotary files manufactured with AF-H Wire technology
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
实验性的：Pediatric NiTi rotary files manufactured with blue wire technology
Pediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited.
设备：Pediatric NiTi rotary files manufactured with blue wire technology
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
instumentation time
大体时间：same visit while performing the pulpectomy
The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch
same visit while performing the pulpectomy

次要结果测量

结果测量
措施说明
大体时间
obturation quality
大体时间：same visit after pulpectomy completion

The quality of obturation will be evaluated according to the criteria of Coll and Sadrian criteria (1996). The apical seal will measured in millimeters from the apical end of the canal filling material to the radiographic apex and scored as 1, 2, or 3.

  1. Apical seal

    • Score 1 (Underfilling): was defined as filling in all canals extending more than 2 mm short of the apex.
    • Score 2 (Ideal filling) was considered when the material reached up to 2 mm short of the radiographic apex or reached the working length in one or more canals.
    • Score 3 (Overfilling) was recorded when the obturating material extended beyond the radiographic apex.
  2. Voids Obturated canals will be assessed for the presence or absence of voids.
same visit after pulpectomy completion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

调查人员

  • 研究主任：Sara A. Mahmoud, Professor、Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月20日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月28日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CU-rania-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅