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Lemon balm scent may ease Kids' dental fear, study hopes

NCT ID NCT07592130

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether breathing in lemon balm essential oil can reduce anxiety and pain in children aged 6 to 10 during dental injections. Forty-five children will be randomly assigned to receive aromatherapy with one of two brands of lemon balm oil or standard care. Researchers will measure anxiety with a child-friendly questionnaire and observe pain behaviors during the procedure.

What this could mean

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

Active substance
Melissa officinalis (lemon balm) essential oil
What this could lead to
If it works, this could offer a simple, non-drug way to help children feel calmer during dental visits.
What could go wrong
This is a small, early-phase trial with only 45 children, so results may not apply broadly. The effect may be due to the pleasant scent rather than the oil itself.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

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 10 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 6 to 10 years at the time of enrollment. * Male or female pediatric patients in good general physical and mental health. * Require mandibular local anesthesia (inferior alveolar nerve block) for pulpotomy or pulpectomy of at least one primary molar. * No previous experience with dental local anesthesia. * Behavior classified as "positive" or "negative but accepting" (categories 2 or 3) according to the Frankl Behavior Rating Scale during the initial examination. * Ability of the child to understand simple verbal instructions appropriate for age. * Parent or legal guardian able and willing to sign written informed consent. * Child willing to provide verbal assent to participate in the study. Exclusion Criteria: * History of previous dental local anesthesia. * Presence of dental emergencies (e.g., acute infection, severe pain, or swelling) requiring urgent treatment. * Known diagnosis of neurological, psychiatric, developmental, or behavioral disorders that may interfere with cooperation or with the assessment of anxiety and pain. * Systemic diseases or medical conditions (American Society of Anesthesiologists \[ASA\] physical status III or higher) that increase procedural risk or preclude participation according to the investigator's judgment. * Current acute upper respiratory conditions, such as common cold, rhinitis, sinusitis, or nasal allergy that could alter the sense of smell or breathing comfort. * Known allergy, hypersensitivity, or adverse reaction to Melissa officinalis, other Lamiaceae plants, essential oils, or components of the products used in the study. * Use of anxiolytics, antidepressants, sedatives, or other psychotropic medications within the last 30 days. * Behavior rated as definitely negative (Frankl category 1) or definitely positive (Frankl category 4) at baseline. * Inability of parents or guardians to understand the study information or provide informed consent. * Participation in another clinical trial within the previous 30 days.

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