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

NCT07754851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Katechi · NKUA

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754851 on ClinicalTrials.gov