Pen vs needle: can a high-tech device calm kids at the dentist?

NCT ID NCT07557160

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Recruitment status, easiest to join first

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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a computer-controlled pen-like device (Dentapen) causes less anxiety in children aged 6-8 during dental numbing compared to a traditional syringe. About 42 children will be randomly assigned to one method, and their anxiety and heart rate will be measured. The goal is to find a more comfortable way to give numbing medicine to kids.

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

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

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

6 to 8 years

Sex

Anyone

Healthy volunteers

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

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 6 and 8 years. * Cooperative children. * Children having normal intellectual development. * Children willing to provide assent and parent willing to provide informed consent. * Healthy children with no systemic problems according to parental history. * First dental visit. * Children with bilaterally maxillary primary molars indicated for extraction. Exclusion Criteria: * Children with medical, physical, or mental conditions. * Children requiring emergency dental treatment (cellulitis, abscess). * Children whose parents refuse to sign the informed consent.

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How to take part

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