New gadget aims to take the ouch out of Kids' dental needles
NCT ID NCT07156396
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study compares a computer-controlled anesthetic device (SleeperOne) to a traditional syringe for numbing kids' teeth before extraction. 28 children aged 3-5 will be randomly assigned to one method. Pain, anxiety, and heart rate will be measured to see if the device makes the injection more comfortable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SleeperOne® device (computer-controlled local anesthetic delivery system) with 3% mepivacaine and 20% benzocaine topical gel
- What this could lead to
- If it works, this could provide a less painful and less scary way to give dental injections to young children, improving their experience and cooperation.
- What could go wrong
- This is a small, early-stage trial with only 28 children, so results may not apply to all kids or settings. The device may not significantly reduce pain compared to the standard method.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 5 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Children Aged between 3 to 5 years. * Medically fit children classified as ASA physical status I and II * Parents acceptance to participate in the study (informed consent) * Children with teeth diagnostically confirmed to require extraction Exclusion criteria: * Patients with an allergy to local anesthesia. * Uncooperative children * Children requiring general anesthesia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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