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Pain-Free fillings? new device aims to take the ouch out of Kids' dental shots

NCT ID NCT07292194

Symptom relief Sponsor: Lamis D. Rajab 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 computer-controlled device called the Super Pen causes less pain during dental numbing shots in children aged 6-12 compared to a standard syringe. Each child received both methods in a split-mouth design, and researchers measured pain through self-reports, behavior, and heart rate. The goal is to find a gentler way to deliver local anesthesia for common dental treatments.

What this could mean

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

Active substance
Super Pen (computer-controlled local anesthesia delivery device)
What this could lead to
If it works, this could give dentists a less painful way to numb kids' teeth for fillings or crowns.
What could go wrong
This is a small, completed study with only 54 children, so results may not apply to all kids or settings. The device may not reduce pain for everyone.

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

54 people

The number who actually took part.

Started

Jan 2026

Finished

Apr 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

6 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: 1. Children who were 6-12 years of age, of both sexes. 2. Children who were healthy and medically fit; ASA I . 3. Children who had positive (Class 3) or definitely positive (Class 4) behavior during preoperative behavioral assessments according to the Frankl Scale at the enrollment visit. 4. Children who require bilateral LA infiltration injections for primary teeth, either in the maxilla or mandible, for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions). 5. Children with positive consent forms approved by their parents/ legal guardians. Exclusion Criteria: 1. Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures. 2. Children with any mental, visual, or auditory impairment. 3. Children who have medical or developmentally compromising conditions. 4. Children who had developmental delay problems. 5. Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics. 6. Children who had active pathosis at the injection site that could affect anesthetic assessment. 7. Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -

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Conditions

The condition(s) this trial relates to.

Toothache

As listed by the trial registrant

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

Injection pain Local anesthesia infiltration Pediatric patient

Contacts and locations

Locations

  • Lamis

    Amman, Jordan

More trials for these conditions

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