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Can a Computer-Controlled injection make dental drilling Pain-Free for kids?

NCT ID NCT07736677

Symptom relief Sponsor: Ege University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether a computer-controlled injection system can reduce pain during dental treatment in children aged 6 to 12 with a condition called molar incisor hypomineralization (MIH), which makes teeth sensitive. The device delivers numbing medicine directly into the bone, and the study compares it to standard numbing shots. The goal is to see if children report less pain during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
computer-controlled intraosseous anaesthesia system (SleeperOne 5)
What this could lead to
If it works, this could offer a less painful way to numb teeth for children with MIH, making dental visits easier.
What could go wrong
This is a relatively small trial, and the device may not prove superior to standard numbing methods for all children.

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

110 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

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 12 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 6-12 years. * Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria. * Presence of an MIH-affected permanent first molar classified as Würzburg Category 1 or 2a and requiring either a direct resin composite restoration or a stainless steel crown. * Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale. * No known allergy to local anaesthetics. * No relevant systemic disease. Exclusion Criteria: * Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment. * Previous experience with intraosseous anaesthesia. * Presence of an acute dentoalveolar infection at the planned treatment site.

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Conditions

The condition(s) this trial relates to.

Molar Hypomineralization Toothache

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Molar incisor hypomineralization

Contacts and locations

Locations

  • Ege University

    Izmir, 35110, Turkey (Türkiye)

  • Istanbul Beykent University

    Istanbul, Turkey (Türkiye)

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