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Pre-Dental ibuprofen may ease pain for kids with tooth inflammation

NCT ID NCT07114198

Symptom relief Sponsor: Inonu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed early-phase trial tested whether giving ibuprofen before dental treatment reduces pain and stress in children with reversible pulpitis (a type of tooth inflammation). 46 children received ibuprofen 40 minutes before the procedure. The study measured pain during and after treatment. Results may help improve pain management in pediatric dentistry.

What this could mean

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

Active substance
Ibuprofen
What this could lead to
If it works, this could point toward a simple way to make dental procedures less painful for children with reversible pulpitis.
What could go wrong
This is a very small, early-phase trial with only 46 participants, so results may not apply to all children. The effect may be small or not clinically meaningful.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

46 people

The number who actually took part.

Started

Aug 2025

Finished

Aug 2025

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 13 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: * Children with no history of systemic disease, * Demonstrated cooperative behaviour during treatment, * Parental consent obtained for study participation, * Presence of a first permanent mandibular molar with: 1. Clinical and radiographic diagnosis of reversible pulpitis, 2. Deep carious lesion extending beyond three-quarters of dentine thickness on periapical/bitewing radiographs (ICDAS score 5-6), 3. Positive cold test response with Endo-Ice (Hygienic Corp., Akron, OH, USA) producing short-lasting pain (subsiding within \<10 seconds after stimulus removal), 4. No clinical signs of swelling, abscess, or sinus tract, 5. Absence of abnormal tooth mobility, 6. Restorability of the tooth. Exclusion Criteria: * Presence of primary teeth requiring treatment, * Clinical or radiographic diagnosis of irreversible pulpitis, necrotic pulp, apical lesion, swelling, abscess, or sinus tract, * Analgesic intake within the preceding 12 hours, * Known allergy to ibuprofen or local anaesthetics, * Neurological or psychiatric developmental disorders, * Presence of systemic illness, * Existing gastrointestinal disease.

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Conditions

The condition(s) this trial relates to.

pulpitis Toothache

As listed by the trial registrant

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

Ibuprofen Reversible pulpitis

Contacts and locations

Locations

  • Inönü University

    Malatya, 44050, Turkey (Türkiye)

More trials for these conditions

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