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NCT07592130

PHASE2

Melissa Officinalis Aromatherapy for Dental Anxiety in Children

Sponsor: Universidad Autonoma de San Luis Potosí

View on ClinicalTrials.gov

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.

Official title: Anxiolytic Effect of Inhaled Melissa Officinalis Essential Oil During Mandibular Local Anesthesia in Pediatric Dental Patients: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-15

Completion Date

2027-02-25

Last Updated

2026-05-18

Healthy Volunteers

Conditions

Emotional Anxiety and Stress During Pediatric Dental Treatment Dental Anesthesia

Interventions

OTHER

Aromatherapy with Melissa officinalis essential oil - Brand A

Melissa officinalis essential oil from Brand A (Young Living, Lehi, Utah, USA) will be placed in an electric nebulizer in the dental operatory at a standardized dilution in 10 mL of sterile distilled water. Diffusion will start 5 minutes before administration of topical anesthetic and inferior alveolar nerve block and will continue throughout the pulpotomy or pulpectomy procedure. Conventional behavioral management (tell-show-do, positive reinforcement, age appropriate communication) will also be used.

OTHER

Aromatherapy with Melissa officinalis essential oil - Brand B

Melissa officinalis essential oil from Brand B (doTERRA, Pleasant Grove, Utah, USA) will be administered with the same nebulizer model and under the same conditions and timing used in the Brand A arm (5 minutes before and during local anesthesia and treatment). Conventional behavioral management will be applied in all cases.

OTHER

Standard behavioral management

Behavioral techniques including tell-show-do, positive reinforcement, euphemistic wording, and modeling when needed will be used to facilitate cooperation during local anesthesia and pulpotomy or pulpectomy, without the use of essential oils.

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.

Clinical Research Directory

Melissa Officinalis Aromatherapy for Dental Anxiety in Children

Summary

Key Details

Conditions

Interventions

Eligibility Criteria