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Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia
Sponsor: Ondokuz Mayıs University
Summary
This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children. Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order. Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded. The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.
Official title: Assessing the Efficacy of the Comfort-in Needle-Free Injection System for Managing Pain and Anxiety During Pediatric Dental Injections: A Randomized Split-Mouth Clinical Trial
Key Details
Gender
All
Age Range
5 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2019-01-01
Completion Date
2021-12-31
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
Comfort-in Needle-Free Injection System
The Comfort-in needle-free injection system was used to administer local anesthetic solution without needle penetration. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in system before pulpotomy treatment of the primary first molar.
Conventional Dental Injection
Conventional local anesthesia was administered using a dental injector. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using a 27-gauge dental injector before pulpotomy treatment of the primary first molar.
Locations (1)
Recep Tayyip Erdogan University
Rize, Rize Province, Turkey (Türkiye)