NCT07106138

Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience

Comparing the Effectiveness of Several Local Anaesthesic Systems and Thier Effect on Pain Anxiety Behaviour and Vital Signs in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Tishreen University · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe, computer-controlled local anesthetic delivery system (Star Pen), needle-free injector (Comfort-In), or a vibrotactile device (Vibraject). Pain was assessed using the FLACC and Wong-Baker FACES scales, anxiety with the Venham Picture Test, and behavior with the Houpt scale. Vital signs including pulse and oxygen saturation were recorded during treatment. Additionally, satisfaction levels of both the patients and their parents were evaluated using structured questionnaires and Likert scales. The study seeks to determine which technique provides the most comfortable and effective experience for children undergoing dental procedures.

Detailed description

Local anesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children. Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial investigated and compared four local anesthetic systems: traditional syringe, computer-controlled local anesthetic delivery (CCLAD) using the Star Pen, needle-free injection using Comfort-In, and vibrotactile stimulation with Vibraject. A total of 112 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of the four anesthesia groups. Pain perception was measured using both the FLACC scale and the Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using the Venham Picture Test before and during the procedure. Child behavior was rated using the Houpt Behavioral Scale. Vital signs including pulse rate and oxygen saturation were monitored at baseline and during treatment. In addition, satisfaction levels were assessed for both the pediatric patients and their accompanying parents, using child-friendly satisfaction questionnaires and parent-rated Likert scales. This study aims to identify the anesthesia delivery method that best minimizes pain and anxiety, optimizes behavior, maintains physiological stability, and maximizes satisfaction, thereby enhancing the quality of care in pediatric dentistry.

Conditions

• Dental Anxiety
• Pain Management
• Pediatric Dentistry

Interventions

Type	Name	Description
DEVICE	Conventional syringe injection	Manual injection using a conventional dental syringe and needle to deliver local anesthetic.
DEVICE	Star Pen	A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.
DEVICE	Comfort-In	A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.
DEVICE	Vibraject	A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception

Timeline

• Start date: 2024-04-23
• Primary completion: 2024-11-29
• Completion: 2025-03-10
• First posted: 2025-08-06
• Last updated: 2025-08-11

Locations

1 site across 1 country: Syria