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Robot numbing vs. Old-School needle: which scares kids less?

NCT ID NCT07156487

Symptom relief Sponsor: Dicle 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study will test whether a computer-controlled anesthesia system (SleeperOne 5) reduces pain and anxiety more than a traditional syringe in 84 children aged 7-10 getting dental fillings. Kids will rate their pain and anxiety using special scales, and their heart rate and temperature will be measured. The goal is to find a gentler way to numb teeth for kids.

What this could mean

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

Active substance
articaine with epinephrine (Ultracaine D-S Fort)
What this could lead to
If successful, this could help dentists choose a less painful, less anxiety-provoking way to numb children's teeth during fillings or extractions.
What could go wrong
This is a small, early-stage study (84 children) that only looks at short-term pain and anxiety. Results may not apply to all kids or dental procedures.

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 84 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Mar 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

7 to 10 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: * Patients classified as ASA I in general systemic health * Children between 7 and 10 years of age * Absence of any syndromic condition * No physical or mental disability * No prior dental treatment experience * Frankl Behavior Rating Scale Class III or IV * Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides * Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides * Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs Exclusion Criteria: * Patients with mild or severe systemic diseases or those undergoing medical treatment * Patients younger than 7 or older than 10 years of age * Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale * Patients requiring urgent dental treatment * Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces * Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw * Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border * Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs

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Conditions

The condition(s) this trial relates to.

anxiety disorder

As listed by the trial registrant

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

Anxiety in children Computer-controlled electronic anesthesia Dental anxiety Traditional local anesthesia

How to take part

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  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

  • Dicle University Faculty of Dentistry, Department of Pediatric Dentistry

    Diyarbakır, 21300, Turkey (Türkiye)

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