Wand STA vs SleeperOne for Pediatric Local Anesthesia (WASO-Kids)

National and Kapodistrian University of Athens72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Dental Anxiety Pain Management

Interventions

Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type)DEVICE

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)DEVICE

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Non-contributory medical history * At least one tooth requiring the same treatment on each side of the same jaw * Teeth on both sides with normal periodontium and no periapical pathology (confirmed radiographically) Exclusion Criteria: * Age outside 4-9 years * History of psychiatric or developmental illness, or allergies * Use of analgesic medication in the preceding 12 hours * History of unpleasant dental treatment experiences

Locations (1)

NKUA

Athens, Greece

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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