An interventional study of Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type) and Computer-controlled local anesthetic delivery system (corded, pen-style electronic type) in Dental Anxiety and Pain Management, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 4 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Supportive care
This randomized, single-blind, split-mouth trial compares the acceptance of two computer-controlled local anaesthetic delivery (CCLAD) systems - Wand® STA and SleeperOne⑤ - in children aged 4-9 years undergoing comparable bilateral dental treatment. Each child receives local anaesthesia via both devices at separate visits, with pain, behaviour, heart rate, and oxygen saturation recorded at each session, to determine whether the two systems differ in child acceptance and physiological response.
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Participants received local anaesthesia using the Wand® STA computer-controlled delivery system at the first treatment session, followed by the SleeperOne⑤ system at the second session, for comparable bilateral dental treatment (split-mouth design).
Device: Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type) · Device: Computer-controlled local anesthetic delivery system (corded, pen-style electronic type)
Participants received local anaesthesia using the SleeperOne⑤ computer-controlled delivery system at the first treatment session, followed by the Wand® STA system at the second session, for comparable bilateral dental treatment (split-mouth design).
Device: Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type) · Device: Computer-controlled local anesthetic delivery system (corded, pen-style electronic type)
A computer-controlled device that delivers local anesthetic through a pen-like handpiece at a constant, programmable flow rate and pressure. Incorporates pressure sensing to enable single-tooth anesthesia via periodontal ligament or infiltration delivery with minimal soft-tissue numbness. Articaine 1:200,000 was administered via this system at one of the two study visits, according to randomized sequence assignment.
A corded, pen-style computer-controlled device that delivers local anesthetic at a programmable injection speed across conventional, intraligamentary, and, in suitable cases, intraosseous techniques. Articaine 1:200,000 was administered via this system at one of the two study visits, according to randomized sequence assignment.
Assessed at the end of each anaesthesia session, at both the first and second study visits
After the second anaesthetic injection, children rated their pain or discomfort using the Wong-Baker FACES Pain Rating Scale, administered by a trained examiner blinded to which device had been used. The scale presents six faces corresponding to scores of 0, 2, 4, 6, 8, and 10, where 0 indicates "no hurt" and 10 indicates "hurts worst"; higher scores indicate greater pain (a worse outcome). Children selected the face that best matched how they felt immediately after the injection
Time frame: Periprocedural
Wong-Baker FACES Pain Score During Local Anaesthesia Injection
After each anaesthetic injection, children rated their pain or discomfort using the Wong-Baker FACES Pain Rating Scale, administered by a trained examiner blinded to which device had been used. The scale presents six faces ranging from 0 (no hurt) to 10 (hurts worst), with children selecting the face that best matched how they felt. Scores were recorded once per session, after the first (Wand® STA or SleeperOne⑤, per randomized sequence) and again after the second anaesthetic delivery visit, allowing comparison both between devices and between sessions.
Time frame: Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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