Melissa Officinalis Aromatherapy for Dental Anxiety in Children

This is a single center, three arm, parallel group, randomized controlled trial in pediatric dental patients. Participants will be randomized in equal proportions (1:1:1) to one of three groups using permuted blocks, with allocation concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Due to the olfactory nature of the intervention, blinding of operators is not feasible; however, outcome assessors who record anxiety, pain scores, and physiological measures will be distinct from the operator and will remain unaware of group allocation until data analysis.

All clinical procedures will be performed by a single calibrated pediatric dentist using a standardized protocol that includes topical lidocaine 10% spray, inferior alveolar nerve block with lidocaine 2% with epinephrine 1:100,000, and subsequent pulpotomy or pulpectomy as indicated. Behavioral management techniques (tell-show-do, positive reinforcement, age appropriate language, and modeling when needed) will be applied in all groups, with the control group receiving only these non pharmacological strategies and no aromatherapy.

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.