Melissa Officinalis Aromatherapy for Dental Anxiety in Children (NCT07592130) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Melissa Officinalis Aromatherapy for Dental Anxiety in Children
45 participantsStarted 2026-06-15
Plain-language summary
This clinical study will look at whether a plant-based essential oil called "Melissa officinalis" (lemon balm) can help reduce fear and stress in children during dental treatment. Children between 6 and 10 years old who need a mandibular injection for a pulpotomy or pulpectomy will be invited to participate. They will be randomly assigned to one of three groups: one group will receive aromatherapy with \*Melissa officinalis\* from brand A, another group will receive the same essential oil from brand B, and a third group will receive the usual behavioral management used in pediatric dentistry, but without aromatherapy.
The essential oil will be diffused in the dental room so that the child can gently inhale the aroma starting a few minutes before the injection and throughout the procedure. The study team will measure the child's dental anxiety using a child-friendly questionnaire with drawings of faces, observe pain behaviors during the injection, and record the child's own rating of pain with a faces scale. Heart rate and oxygen saturation will also be monitored as objective signs of stress. The goal is to find out whether "Melissa officinalis" aromatherapy is a safe, simple, non-invasive way to make dental visits less stressful and more comfortable for children, and whether there are meaningful differences between the two commercial products.
Who can participate
Age range
6 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in dental anxiety (MCDASf score)
Timeframe: From baseline before the dental appointment to immediately after local anesthetic injection (approximately 15-20 minutes).