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Can a Computer-Controlled injection ease Kids' dental fear?

NCT ID NCT07741487

Symptom relief Sponsor: Ankara 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This trial tests whether a computer-controlled anesthesia device, SleeperOne® 5, can reduce pain and anxiety compared to a standard dental injection in children aged 8-14 with molar-incisor hypomineralization (MIH), a condition causing weak enamel. Each child receives both anesthesia methods in separate sessions, and their pain, behavior, heart rate, and oxygen levels are measured. The goal is to see if this technology makes dental treatment more comfortable for children with MIH.

What this could mean

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

Active substance
SleeperOne® 5 computer-controlled intraosseous anesthesia device
What this could lead to
If effective, this device could offer a less painful and less anxiety-provoking alternative to standard dental injections for children with MIH, improving their dental experience.
What could go wrong
This is a small, early-stage trial (35 children) and results may not apply to all children or settings. The device may not always outperform conventional anesthesia, and there are inherent risks with any local anesthetic procedure.

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

35 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

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

8 to 14 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 8 to 14 years. * Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment. * MIH diagnosed according to EAPD criteria. * Positive or definitely positive Frankl Behavior Rating Scale. * Parent or guardian provided written informed consent. Exclusion Criteria: * Acute pulpal or periapical pathology. * Developmental dental anomalies other than MIH. * Allergy to local anesthetic agents. * Medical contraindication to local anesthesia. * Analgesic or anti-inflammatory drug use within 24 hours before treatment. * Cognitive or communication disorders affecting study assessments. * Uncooperative behavior.

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Conditions

The condition(s) this trial relates to.

Molar Hypomineralization

As listed by the trial registrant

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

Molar incisor hypomineralisation

Contacts and locations

Locations

  • Ankara University Faculty of Dentistry

    Ankara, 06560, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.