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No more needles? new device could make dental shots painless for kids

NCT ID NCT07585812

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a needle-free injection system called Comfort-in to see if it could reduce pain and anxiety in children during dental procedures. Sixty children aged 5 to 8 who needed dental work on both sides of their mouth received both the needle-free system and a conventional needle injection in separate visits. The researchers measured pain using behavioral scales and self-reports to compare the two methods.

What this could mean

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

Active substance
Comfort-in Needle-Free Injection System
What this could lead to
If it works, this could make dental injections less painful and scary for children, improving their experience and cooperation.
What could go wrong
This is a small, completed trial with 60 children. Results may not apply to all kids or dental procedures, and the device may not be widely available.

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

60 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2021

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

5 to 8 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 5 to 8 years. * Children requiring pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible. * Children with no previous experience of local anesthesia or dental treatment. * Children who showed positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination. * Children with no systemic disease. * Children with no mental or cognitive disability. * Children who had not used medications that could affect pain perception, including antibiotics or analgesics. * Written informed consent obtained from the parents or legal guardians. Exclusion Criteria: * Previous dental treatment experience. * Previous local anesthesia experience. * Uncooperative behavior during the initial examination. * Presence of systemic disease. * Presence of mental or cognitive disability. * Antibiotic use within the last month. * Analgesic use within the last 24 hours. * Use of any medication that could influence pain perception. * Refusal of parental or legal guardian consent.

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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.

Dental anxiety Dental pain Local anesthesia Pulpotomy

Contacts and locations

Locations

  • Recep Tayyip Erdogan University

    Rize, Rize Province, 53000, Turkey (Türkiye)

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