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临床试验/NCT07095946
NCT07095946招募中不适用

Comparing the Effectiveness of the Intraligament Anesthesia Technique With the Inferior Alveolar Nerve Block Technique Using the Electronic Syringe in Children: A Random Clinical Study

Tishreen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Success rate of electronic syringe anesthesia in pediatric dental procedures

研究概览

简要总结

This randomized clinical study aims to evaluate the efficacy and pain response of two local anesthesia techniques in pediatric dental treatment using an electronic syringe: ligament anesthesia and inferior alveolar nerve block (IANB). The study applies both techniques to the same sample, where each child undergoes pulpectomy for two different teeth, each under the influence of a different anesthesia technique, during two separate visits.

This study comes in the context of technological advancements in dentistry, which led to the development of computerized syringes as an alternative to traditional syringes. These devices are characterized by precise control of the anesthetic flow rate, as well as containing musical and auditory systems aimed at distracting the child and reducing feelings of fear and anxiety associated with dental treatment. Additionally, computerized syringes provide audible indicators showing the amount of anesthetic injected and support multiple injection modes such as rapid injection, slow injection, and ligament injection, allowing for more efficient and comfortable anesthetic delivery.

Pain intensity will be assessed during three stages of the treatment procedure: during anesthesia administration, during placement of the rubber dam, and during opening of the pulp chambers. Post-procedure pain will also be evaluated using an age-appropriate validated pain scale, along with assessing the satisfaction level of both the children and their parents regarding the use of the electronic syringe as an alternative anesthesia tool. These combined measures aim to provide a comprehensive understanding of the child's experience during dental treatment and contribute to improving anesthesia practices in pediatric dentistry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Cooperative children based on Frankl Behavior Rating Scale (Positive or Definitely Positive)
  • •No clinical signs or symptoms indicating irreversible pulpitis
  • •No periodontal ligament inflammation of the tooth to be treated
  • •Children aged between 5 and 9 years
  • •Children without systemic health problems

排除标准

  • •Children who are uncooperative based on Frankl Behavior Rating Scale (Negative or Definitely Negative)
  • •Presence of spontaneous or nocturnal pain
  • •Clinical signs and symptoms indicating irreversible pulpitis
  • •Presence of periodontal ligament inflammation of the treated tooth
  • •Child age older than 10 years or younger than 3 years
  • •Children with systemic health problems

研究组 & 干预措施

Electronic Syringe - IANB Technique

Experimental

Children receive inferior alveolar nerve block (IANB) using an electronic syringe. The injection is performed with controlled speed and pressure to ensure efficient pulpal anesthesia with minimal discomfort.

干预措施: Electronic syringe IANB Technique (Device)

Electronic Syringe - Intraligamentary Technique

Experimental

Children receive intraligamentary anesthesia using an electronic syringe. The anesthetic is administered around the tooth ligament to provide localized anesthesia with minimal invasiveness and reduced discomfort.

干预措施: Electronic Syringe Intraligament Technique (Device)

结局指标

主要结局

Success rate of electronic syringe anesthesia in pediatric dental procedures

时间窗: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening)

Success rate of anesthesia technique

时间窗: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening.)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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