Wand STA vs SleeperOne for Pediatric Local Anesthesia (WASO-Kids) (WASO-Kids)
4. august 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Athens, Grækenland
- NKUA
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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).
|
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.
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.
|
|
Eksperimentel: 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).
|
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessed at the end of each anaesthesia session, at both the first and second study visits
Tidsramme: Periprocedural
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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
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Wong-Baker FACES Pain Score During Local Anaesthesia Injection
Tidsramme: 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.
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Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Katechi, NKUA
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. maj 2025
Primær færdiggørelse (Faktiske)
30. januar 2026
Studieafslutning (Faktiske)
30. januar 2026
Datoer for studieregistrering
Først indsendt
16. juli 2026
Først indsendt, der opfyldte QC-kriterier
4. august 2026
Først opslået (Faktiske)
10. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 634/26.02.2024
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