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No-Needle dental numbing: could a new device spare kids the shot?

NCT ID NCT06576609

Symptom relief Sponsor: University of Jazan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a needleless device (INJEX) can reduce pain and improve behavior in children aged 7-10 during dental fillings compared to a traditional syringe. Fifty children received both methods in different teeth, and researchers measured pain using the FLACC scale and behavior with the Frankel scale. The goal is to find a less frightening and more comfortable way to numb kids' teeth for dental work.

What this could mean

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

Active substance
INJEX needleless anesthesia device
What this could lead to
If it works, this could offer a less painful and less scary way to numb children's teeth for fillings, improving their dental experience.
What could go wrong
This is a small, completed study with only 50 children, so results may not apply to all kids or dental procedures. The device may still cause some discomfort or not work as well as expected.

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

50 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

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

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 7 - 10 years * Existence of deep carious Primary molar, indicated for Indirect pup capping. * Complete physical and mental health without any confounding medical history * Parents who gave written informed consent Exclusion Criteria: * Children below 7 years of age * Children complaining of irreversible pulpitis. * Children with Negative behaviour according to the wright's modification of * Frankl Behaviour Rating scale (FBRS) during initial examination * Children with medical or mentally compromised

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Conditions

The condition(s) this trial relates to.

Child Behavior dental caries dentin caries

As listed by the trial registrant

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

Child behavior

Contacts and locations

Locations

  • College of Dentistry

    Jizan, Jazan Region, 45142, Saudi Arabia

More trials for these conditions

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