Effectiveness of Needle-Free Infiltration Anesthesia in Reduction of Dental Pain and Anxiety During Local Anesthesia.

Summary

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.

Conditions

• This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia

Interventions

DEVICE

INJEX 30

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.

PROCEDURE

Traditional syringe

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

Sponsors & Collaborators

• Damascus University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-28

Primary Completion

2025-11-26

Completion

2025-11-26

Countries

• Syria