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临床试验/NCT07426523
NCT07426523已完成不适用

Evaluation of the Effectiveness of Needle-Free Infiltration Anesthesia in Alleviating Dental Pain and Anxiety Among Children During Local Anesthesia. Randomized Controlled Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年5月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Dental Pain - FLACC Scale

研究概览

简要总结

Local anesthesia is a common and essential procedure for the majority of dental treatments. The most frequently used method of administration is needle injection. Although this technique effectively controls pain, the sight of the needle and the pain experienced during injection often cause fear and anxiety, especially in children. This can lead to negative attitudes toward dental treatment, highlighting the need for less painful alternatives for delivering local anesthesia.

This randomized clinical trial aimed to evaluate the effectiveness of the needle-free INJEX 30 device in reducing pain and anxiety in children aged 6 to 9 years.

Eligible children requiring local anesthesia in the mandibular primary molar region for therapeutic dental procedures were randomly assigned to two groups according to the type of injection system used (INJEX or conventional syringe).

Immediately after the administration of local anesthesia, anxiety was assessed using a physiological measure (plus rate), and pain was evaluated using a self-reported scale (Wong-Baker Faces Pain Scale). Pain was also assessed using a non-self-reported behavioral scale (FLACC) based on video recordings taken during anesthesia administration.

The findings of this study provide clinical evidence about the effectiveness of the INJEX device in reducing pain and anxiety during local anesthesia in pediatric dental patients, which thereby improving clinical decision-making and enhancing the quality of dental care for children.

详细描述

Local anesthesia is a cornerstone of pediatric dental treatment, allowing clinicians to perform restorative and preventive procedures while minimizing pain and discomfort. Nevertheless, administering local anesthesia in children presents several challenges. Achieving profound anesthesia can be difficult in some cases due to anatomical variations, while the risk of local anesthetic toxicity is increased because of the child's lower body weight. Most importantly, fear of needles and pain during injection often provoke anxiety and unpredictable behavioral responses, which can complicate dental treatment and negatively affect the child's overall experience.

The inferior alveolar nerve block is commonly used for pulp therapy of lower primary molars, as it provides relatively deep and long-lasting anesthesia. However, this technique is associated with several disadvantages, including a higher risk of soft tissue injury, prolonged numbness, and greater discomfort during injection. Additionally, inferior alveolar nerve block injections are generally perceived as more painful than infiltration anesthesia techniques, particularly in pediatric patients.

Despite the effectiveness of conventional nerve block techniques, their limitations in children highlight the need for alternative anesthesia methods that are less painful while maintaining adequate anesthetic efficacy. Therefore, a different anesthetic approach with a shorter duration but comparable effectiveness was considered. For this purpose, a needle-free, pressure-based injection system was used in the present study.

Needleless injection devices, such as the INJEX system, deliver local anesthetic solutions into the tissues using high pressure, eliminating the need for conventional needles.

This study aimed to evaluate and compared the effectiveness of the INJEX device and the conventional syringe technique in administering local anesthesia for lower primary molars, with a particular focus on pain perception and anxiety reduction. Both subjective pain assessment scales and objective physiological and behavioral measures were employed to provide a comprehensive evaluation. By identifying anesthetic techniques that reduce pain and anxiety while maintaining clinical effectiveness, this research seeked to improve the quality of pediatric dental care and promote more positive dental experiences for children

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Children aged 6-9 years with no previous dental experience.
  • Children classified as positive or definitely positive according to the Frankl behavior rating scale.
  • Children requiring local anesthesia in the lower primary molar region for therapeutic dental procedures

排除标准

  • Children with systemic diseases that contraindicate the administration of local anesthesia or the required dental treatment.
  • Children who have received sedative or analgesic medications within the 3 hours preceding the dental visit

研究组 & 干预措施

0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administer

Experimental

干预措施: INJEX 30 (Device)

1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidoc

Active Comparator

干预措施: Traditional syringe (Procedure)

结局指标

主要结局

Dental Pain - FLACC Scale

时间窗: During local anesthesia administration, from insertion of the device into the oral cavity until completion of the anesthetic delivery and removal of the device.

Pain during local anesthesia administration will be evaluated using the FLACC behavioral observational scale (Face, Legs, Activity, Cry, Consolability). Scores range from 0-10: 0 = Relaxed 1-3 = Mild discomfort 4-6 = Moderate discomfort 7-10 = Severe discomfort Measurements will be recorded continuously during the administration of local anesthesia.

Dental Pain - Wong-Baker Faces Scale

时间窗: Immediately after local anesthesia administration

Pain will be self-assessed by the child using the Wong-Baker Faces Pain Rating Scale, consisting of six faces ranging from happiest (0 = no pain) to saddest (10 = severe pain). The child will be instructed to choose the face that best represents their pain immediately after local anesthesia administration.

Dental Anxiety - Pulse Rate

时间窗: Baseline and immediately after local anesthesia administration

Dental anxiety will be estimated objectively by measuring pulse rate (beats per minute, bpm) using a pulse oximeter. Measurements will be taken at two time points: 1. At baseline (pre-procedure, at set) 2. Immediately after local anesthesia administration

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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