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Wand STA vs SleeperOne for Pediatric Local Anesthesia (WASO-Kids)
Sponsor: National and Kapodistrian University of Athens
Summary
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.
Official title: A Randomized Controlled Trial of the Acceptance of Two Computer-controlled Anaesthetic Delivery Systems in Paediatric Patients
Key Details
Gender
All
Age Range
4 Years - 9 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2025-05-05
Completion Date
2026-01-30
Last Updated
2026-08-10
Healthy Volunteers
Yes
Conditions
Interventions
Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia 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.
Computer-controlled local anesthetic delivery system (corded, pen-style electronic type)
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.
Locations (1)
NKUA
Athens, Greece