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임상시험

Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia

NCT: NCT07585812 · COMPLETED

NCT IDNCT07585812
상태COMPLETED
시작일2019-01-01
완료2021-12-31
SponsorOndokuz Mayıs University (OTHER)
First posted
Last updated

간략 요약

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.

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