An interventional study of INJEX 30 and Traditional syringe in This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Damascus University · Not applicable, Interventional, and Supportive care
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.
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
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This study's enrollment of 52 is below the median of 84 across 123 interventional studies indexed under Toothache.
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Exclusion Criteria:
Children who have received sedative or analgesic medications within the 3 hours preceding the dental visit
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Device: INJEX 30
Procedure: Traditional syringe
Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group. The dental procedure was then explained to the child using the "Tell-Show-Do" technique. A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia. 1. group: 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administered locally by infiltration using the INJEX 30 device. 2. group :1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidocaine will be administered using a conventional syringe as an inferior alveolar nerve block.
After obtaining the general medical history of each child, comprehensive clinical and radiographic examinations were performed to assess the feasibility of performing dental procedures in the lower primary molar region under local anesthesia. Written informed consent was obtained from the parents or legal guardians for both the dental procedure and the child's participation in the study. Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group. Prior to the procedure, the child's pulse was measured using a physiological monitor (Plus Oximeter). The dental procedure was then explained to the child using the "Tell-Show-Do" technique. A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia. In this group, serving as the control, local anesthesia was administered using the conventional technique (inferior alveol
Dental Pain - FLACC Scale
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.
Time frame: 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
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.
Time frame: Immediately after local anesthesia administration
Dental Anxiety - Pulse Rate
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
Time frame: Baseline and immediately after local anesthesia administration
Plan to share: No
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