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.
Age range
6 Years – 9 Years
Sex
ALL
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Dental Pain - FLACC Scale
Timeframe: During local anesthesia administration, from insertion of the device into the oral cavity until completion of the anesthetic delivery and removal of the device.
Dental Pain - Wong-Baker Faces Scale
Timeframe: Immediately after local anesthesia administration
Dental Anxiety - Pulse Rate
Timeframe: Baseline and immediately after local anesthesia administration