Dental AnxietyWASO-KidsNCT07754851
Wand STA vs SleeperOne for Pediatric Local Anesthesia (WASO-Kids)
A study of Dental Anxiety and Pain Management, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain Management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGreece
- Study dates
- 5 May 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Anxiety, Pain Management
- Being tested
- Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type), Computer-controlled local anesthetic delivery system (corded, pen-style electronic type)
- Keywords
- wand sta, sleeper one, compute red-controlled anesthetic delivery, cclad, pediatric dentistry, local anesthesia, dental injection, child behavior
- Medical subject headings
- Agnosia, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start5 May 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment (split-mouth design; each participant serves as their own control)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Katechi, National and Kapodistrian University of Athens
- Investigators
- Katechi, Principal investigator, NKUA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754851
- Sponsor's protocol ID
- 634/26.02.2024
- Acronym
- WASO-Kids
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Acceptance of Two Computer-controlled Anaesthetic Delivery Systems in Paediatric Patients
- ClinicalTrials.gov ID
- NCT07754851
- Acronym / sponsor ID
- WASO-Kids / 634/26.02.2024
- Conditions
- Dental Anxiety, Pain Management
- Keywords
- wand sta, sleeper one, compute red-controlled anesthetic delivery, cclad, pediatric dentistry, local anesthesia, dental injection, child behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment (split-mouth design; each participant serves as their own control)
| Arm | Type | Receives |
|---|---|---|
| Wand STA → SleeperOne | Experimental | 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)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). |
| SleeperOne → Wand STA | Experimental | 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)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). |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | SleeperOne → Wand STA, Wand STA → SleeperOne |
| 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. | Device | SleeperOne → Wand STA, Wand STA → SleeperOne |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katechi principal investigator
NKUA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dental Anxiety and Pain Management, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessed at the end of each anaesthesia session, at both the first and second study visits (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.