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Cold therapy could replace needle numbing for Children's dental work

NCT ID NCT07198022

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether cold application (cryotherapy) works as well as standard numbing gels and sprays to reduce pain from dental injections in children. 100 kids aged 7 to 10 were divided into four groups: one received a lidocaine spray, one a benzocaine gel, one cold distilled water, and one cold lidocaine spray. Researchers measured pain, anxiety, taste, and vital signs to see which method worked best.

What this could mean

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

Active substance
lidocaine, benzocaine, and cryotherapy (distilled water)
What this could lead to
If successful, this could show that cold application (cryotherapy) works as well as numbing gels or sprays for reducing pain from dental injections in children.
What could go wrong
This is a small, completed Phase 4 study with only 100 children, so results may not apply to all kids or settings. Cryotherapy might not be as effective as standard anesthetics 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

100 people

The number who actually took part.

Started

Sep 2025

Finished

Jan 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

7 to 10 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: * 7 to 10 years old, * Literate, * ASA score 1 and 2, * FRANKL score 3 and 4 * Modified Dental Anxiety score less than 19, * Not allergic to the active ingredient of the topical anaesthetics used * Indication for treatment of primary teeth, * Children who have never had dental treatment under local anaesthesia, * Patients who agree to participate in the study will be included in the study Exclusion Criteria: * Not between the ages of 7 and 10, * Illiterate, * ASA score greater than 2, * FRANKL score 1 and 2 * Modified Dental Anxiety score greater than 19, * Known allergy to the active ingredient of the topical anaesthetics used * Children with previous dental experience will not be included in the study

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As listed by the trial registrant

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

Cryotherapy Healthy Pediatric dentistry Topical anesthesia

Contacts and locations

Locations

  • Ondokuz Mayıs University, Faculty of Dentistry

    Samsun, Turkey (Türkiye)

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