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

NCT07754851 | Completed

• 1 other identifier: 634/26.02.2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety; Pain Management

Keywords

wand sta; sleeper one; compute red-controlled anesthetic delivery; cclad; pediatric dentistry; local anesthesia; dental injection; child behavior

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment

Study Arms (2)

Wand STA → SleeperOne

EXPERIMENTAL

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)

SleeperOne → Wand STA

EXPERIMENTAL

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)

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.

SleeperOne → Wand STA; Wand STA → SleeperOne

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.

SleeperOne → Wand STA; Wand STA → SleeperOne

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

NKUA

Athens, Greece

Location

MeSH Terms

Conditions

Agnosia; Child Behavior

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Katechi

  NKUA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Student

Model Details: Crossover Assignment (split-mouth design; each participant serves as their own control)

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 10, 2026
• Study Start: May 5, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

GR (1)