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

August 4, 2026 updated by: Victoria Katechi, National and Kapodistrian University of Athens

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wand STA → SleeperOne
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)
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.
Device: 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.
Experimental: SleeperOne → Wand STA
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)
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Periprocedural
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.
Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Katechi, NKUA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 634/26.02.2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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