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No-Needle dental shot could spare kids pain and fear

NCT ID NCT07548892

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares a needle-free injection system to a traditional dental syringe for numbing children's teeth before extraction. About 60 healthy kids aged 6 to 12 will be randomly assigned to one method. Researchers will measure their anxiety, pain, and vital signs to see if the needle-free approach is less stressful.

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 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

6 to 12 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: * Being between 6-12 years of age * Having a primary tooth to be extracted with buccal and lingual anesthesia * Being in category 2, 3, or 4 according to the Frankl Behavior Scale * Being systemically healthy * No known history of allergy to local anesthetics * No antibiotic use in the last month and no analgesic use in the last 12 hours * Not having acute dental pain * Having sufficient cognitive ability to understand the anxiety assessment scales * Voluntary participation with written parental consent Exclusion Criteria: * Being under 6 years of age or over 12 years of age * Displaying category 1 behavior according to the Frankl scale * Presence of severe acute dental infection or a condition requiring emergency intervention * Presence of a requirement for surgical extraction in the tooth indicated for extraction * Incomplete root development of the underlying permanent tooth * History of systemic disease (for example heart disease, uncontrolled asthma, epilepsy, diabetes) * Inability to use pain/anxiety scales due to neurological or developmental disorder * History of allergic reaction to local anesthetics or other drugs used * Presence of hypersensitivity to odors or inhalation intolerance * Refusal of participation by the child or parent

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Conditions

The condition(s) this trial relates to.

Pain, Procedural

As listed by the trial registrant

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

Anesthesia, dental Dental anxiety Procedural pain Tooth extraction

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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