Melissa Officinalis Aromatherapy for Dental Anxiety in Children
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-10
SponsorUniversidad Autonoma de San Luis Potosí
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Aromatherapy with Melissa officinalis essential oil - Brand A
- Aromatherapy with Melissa officinalis essential oil - Brand B
- Standard behavioral management
Treatment groups
45 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov