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Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (RCT)

2026年7月29日 更新者:Nehal Salman、Pharos University in Alexandria

Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (Randomized Clinical Trial)

Pain and anxiety management during injection of local anesthesia are major challenges in pediatric dentistry. The injection of local anesthesia is often perceived by children as the most painful step , The introduction of computerized control local anesthetic delivery systems (CCLADS), such as the Star Pen device, has provided a modern approach for reducing discomfort during anesthesia. Additionally, the integrated music distraction feature enhances relaxation and cooperation during treatment.

研究概览

详细说明

: the aim of this study is to evaluate star pen computerized Local Anaesthesia in reducing child pain during injection, and its impact on child behavior during extraction of primary molars.

Materials and Methods: The research will be conducted in the form of a double-blind randomized controlled clinical trial with a parallel design. A total of 40 healthy children aged 4-6 years will be selected from the Pediatric Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria, Egypt. Cooperative Children with Frankl behavioral rating scale scores of 3 or 4 will be selected. Each child chosen will have at least one maxillary or mandibular primary molar that requires extraction. The guardian's written informed consent will be obtained. Participants will be assigned into two groups of 20 children each based on the dental arch where the extraction will be performed: Group I (mandibular group); and Group II (maxillary group). Each group will be further subdivided into two subgroups: test group using the star pen computerized local anesthesia, and control group using the conventional method; IANB in the mandible, and infiltration local anesthesia in the maxilla according to the method of delivery of local anaesthesia. In the present study, pain during injection will be assessed by three methods: physiologically using the heart rate, objectively using Sound, Eye, Motor (SEM) scale, and subjectively using a modified face scale from the Maunuksela scale. In each child extraction of one primary molar will be performed according to the AAPD and child behavior will be assessed using Frankl Rating Scale.

Results: To obtain the study's results and conclusions, data will be collected, tabulated, and statistically analysed using SPSS version 26.0, with a significance level set at p < 0.05.

研究类型

介入性

注册 (实际的)

40

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。

学习地点

      • Alexandria、埃及
        • Pharos University in Alexandria

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. Completion of the written informed consent form by parents/guardian.
  2. Children aged between 4 and 6 years.
  3. Medically fit patients classified as (ASA I).
  4. Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4.
  5. Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD).

Exclusion Criteria:

  1. Children with a history of allergy to local anaesthetic agents.
  2. Children who receive any analgesic drugs at least 24 h before treatment.
  3. Any inflammation or lesion in the injection site.
  4. Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences.
  5. Child coming for emergency treatment of pain.
  6. Teeth with ankylosed roots.

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Mandibular (IANB)
CCLADS
infiltration or inferior alveolar local anesthesia
实验性的:Maxillary Infiltration
CCLADS
infiltration or inferior alveolar local anesthesia

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
heart rate
大体时间:The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
measuring heart rate by pulse oximeter
The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
Sound, Eye, Motor (SEM) Scale
大体时间:will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
objective method for pain assessment during LA administration scores from 1-->4 score 1=comfort(low score) score 4=severe discomfort (high score)
will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.

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。

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 (实际的)

2026年1月1日

初级完成 (实际的)

2026年6月1日

研究完成 (实际的)

2026年6月1日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 460 - 6/01/2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

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