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Computerized needle aims to take the ouch out of Kids' dental shots

NCT ID NCT07688018

Symptom relief Sponsor: Pharos University in Alexandria 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This trial tests whether a computerized device called the Star Pen can reduce pain and anxiety in children aged 4 to 6 during dental numbing injections. The device delivers anesthetic slowly and steadily, and includes music to help kids relax. Researchers will compare it to a standard syringe by measuring heart rate and observing children's reactions.

What this could mean

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

Active substance
Star Pen computerized local anesthesia device
What this could lead to
If effective, this device could make dental injections less painful and less scary for young children, improving their experience and cooperation.
What could go wrong
This is a small, early-stage trial with only 40 children. Results may not apply to all kids or dental procedures, and the device may not reduce pain significantly more than standard methods.

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

40 people

The number who actually took part.

Started

Jan 2026

Finished

Jun 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

4 to 6 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: 1. Completion of the written informed consent form by parents/guardian. 2. Children aged between 4 and 6 years. 3. Medically fit patients classified as (ASA I). 4. Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4. 5. Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD). Exclusion Criteria: 1. Children with a history of allergy to local anaesthetic agents. 2. Children who receive any analgesic drugs at least 24 h before treatment. 3. Any inflammation or lesion in the injection site. 4. Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences. 5. Child coming for emergency treatment of pain. 6. Teeth with ankylosed roots.

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As listed by the trial registrant

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

Computer-controlled local anesthesia

Contacts and locations

Locations

  • Pharos university in Alexandria

    Alexandria, Egypt

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