Skip to main content
OpenTrials
Completed

NCT Number: NCT07754851

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Anxiety Agnosia Behavior Child Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NKUA

Athens, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessed at the end of each anaesthesia session, at both the first and second study visits

    Time frame: Periprocedural

    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

  2. Wong-Baker FACES Pain Score During Local Anaesthesia Injection

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

    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.

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

A Randomized Controlled Trial of the Acceptance of Two Computer-controlled Anaesthetic Delivery Systems in Paediatric Patients

Acronym: WASO-Kids

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.