Melissa Officinalis Aromatherapy for Dental Anxiety in Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 b
• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in dental anxiety (MCDASf score) [Срок оценки: From baseline before the dental appointment to immediately after local anesthetic injection (approximately 15-20 minutes).]

Вторичные конечные точки (5)

• Observed pain during needle insertion (SEM scale) [Срок оценки: During needle insertion and anesthetic injection (approximately 1-2 minutes).]
• Self reported pain after treatment (Wong-Baker Faces) [Срок оценки: Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).]
• Heart rate during dental treatment [Срок оценки: Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).]
• Oxygen saturation during dental treatment [Срок оценки: Baseline, during injection, and post treatment (approximately 20-30 minutes).]
• Adverse events related to Melissa officinalis essential oil [Срок оценки: From the start of aromatherapy (or entry into the operatory for the control group) to 30 minutes after the end of the dental procedure (single visit).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Yadav A, Bailwad SA, Bhatnagar A, Roy M. Evaluation of the effect of essential oil aromatherapy on anxiety and pain during administration of local anesthesia in children: a randomized clinical trial. J Dent Anesth Pain Med. 2024 Dec;24(6):395-406. doi: 10.17245/jdapm.2024.24.6.395. Epub 2024 Nov 26. PMID 39697190
• Nirmala K, Kamatham R. Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. J Caring Sci. 2021 Aug 23;10(3):111-120. doi: 10.34172/jcs.2021.026. eCollection 2021 Aug. PMID 34849354
• Rigillo G, Blom JMC, Cocchi A, Martinucci V, Favaro F, Baini G, Cappellucci G, Tascedda F, Biagi M. Medicinal Plants for Child Mental Health: Clinical Insights, Active Compounds, and Perspectives for Rational Use. Children (Basel). 2025 Aug 28;12(9):1142. doi: 10.3390/children12091142. PMID 41007011

Идентификаторы

NCT: NCT07592130 · U.A.S.L.P. Estomatología · No funding

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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