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Can a computer-controlled injection make dental visits less painful for kids with sensitive teeth?

NCT ID NCT07733011

Symptom relief Sponsor: Marmara 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a computer-controlled local anesthesia device causes less pain and anxiety than a traditional injection in children aged 8-12 with molar-incisor hypomineralization (MIH), a condition that makes teeth sensitive. Each child will receive both methods on different teeth to compare comfort, effectiveness, and preference. The goal is to find a gentler way to numb teeth before dental treatment.

What this could mean

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

Active substance
a computer-controlled local anesthetic delivery system (SleeperOne) using 4% articaine with epinephrine
What this could lead to
If it works, this could point toward a less painful dental experience for children with sensitive teeth due to MIH.
What could go wrong
This is a small, early-stage trial with only 54 children, so results may not apply to all kids or dental procedures. The device may not reduce pain or anxiety as hoped.

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 54 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

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

8 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 8-12 years * Children with no systemic disease * Children with no pathology involving the oral region, such as trauma, cysts, or tumors * Children who have not used antibiotics within the past month * Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month * Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries * Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study Exclusion Criteria: * Children in whom local anesthesia cannot be administered due to lack of cooperation * Children who require pulp treatment after enrollment in the study will be withdrawn from the study.

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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.

Computer-controlled local anesthesia Molar incisor hypomineralization Molar-incisor hypomineralization (MIH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi

    Istanbul, Maltepe, 34854, Turkey (Türkiye)

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