Melissa Officinalis Aromatherapy for Dental Anxiety in Children (No acronym)
Anxiolytic Effect of Inhaled Melissa Officinalis Essential Oil During Mandibular Local Anesthesia in Pediatric Dental Patients: A Randomized Controlled Clinical 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Dhira Limón-Ramírez, DDS
- Telefonní číslo: 52 1 844 196 05 15
- E-mail: dhiraramirez0@gmail.com
Studijní záloha kontaktů
- Jméno: Miguel Rosales-Berber, M.Sc,
- Telefonní číslo: +52 1 444 131 8166
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Aromatherapy with Melissa officinalis essential oil - Brand A
Children will receive aromatherapy with Melissa officinalis essential oil (Brand A) in addition to standard non pharmacological behavioral management during a mandibular local anesthetic procedure for pulpotomy or pulpectomy. A standardized dilution of Melissa officinalis essential oil from Brand A (Young Living, Lehi, Utah, USA) in 10 milliliters of sterile distilled water will be added to an electric nebulizer in the dentist office. Diffusion will begin five minutes prior to the topical anesthetic and inferior alveolar nerve block being administered, and it will continue during the pulpotomy or pulpectomy process. Additionally, age-appropriate communication, positive reinforcement, and tell-show-do behavioral control techniques will be employed. |
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.
Ostatní jména:
|
|
Experimentální: Aromatherapy with Melissa officinalis essential oil - Brand B
Children will receive aromatherapy with Melissa officinalis essential oil (Brand B) in addition to standard non pharmacological behavioral management during a mandibular local anesthetic procedure for pulpotomy or pulpectomy. The same nebulizer model, timing, and circumstances as the Brand A arm will be utilized to give Melissa officinalis essential oil from Brand B (doTERRA, Pleasant Grove, Utah, USA) (5 minutes before and during local anesthesia and treatment). In every situation, traditional behavioral management will be used. |
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.
Ostatní jména:
|
|
Aktivní komparátor: Standard behavioral management
Children will receive standard non pharmacological behavioral management during the mandibular local anesthetic procedure and restorative treatment, with no aromatherapy or additional olfactory stimulus in the operatory. Without the use of essential oils, behavioral strategies such as tell-show-do, positive reinforcement, euphemistic language, and modeling where necessary will be employed to promote compliance during local anesthetic and pulpotomy or pulpectomy. |
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in dental anxiety (MCDASf score)
Časové okno: From baseline before the dental appointment to immediately after local anesthetic injection (approximately 15-20 minutes).
|
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale with faces (MCDASf).
Scores will be recorded at baseline (before exposure to the operatory or aromatherapy) and after completion of local anesthetic injection.
The outcome is the change in MCDASf score (post anesthesia minus baseline) and will be compared among the three study groups.
|
From baseline before the dental appointment to immediately after local anesthetic injection (approximately 15-20 minutes).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Observed pain during needle insertion (SEM scale)
Časové okno: During needle insertion and anesthetic injection (approximately 1-2 minutes).
|
Pain behavior during administration of the inferior alveolar nerve block will be evaluated using the Sound, Eye, Motor (SEM) scale by an independent, trained observer.
Higher scores indicate more intense behavioral signs of pain.
|
During needle insertion and anesthetic injection (approximately 1-2 minutes).
|
|
Self reported pain after treatment (Wong-Baker Faces)
Časové okno: Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).
|
After completion of the dental procedure, children will rate their pain using the Wong-Baker Faces Pain Rating Scale (0-10).
Higher scores indicate greater perceived pain intensity.
|
Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).
|
|
Heart rate during dental treatment
Časové okno: Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).
|
Heart rate will be measured with a digital pulse oximeter at three time points: baseline (seated in the operatory), during the local anesthetic injection, and after completion of treatment.
The outcome will be the mean heart rate and its change across time points within and between groups.
|
Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).
|
|
Oxygen saturation during dental treatment
Časové okno: Baseline, during injection, and post treatment (approximately 20-30 minutes).
|
Peripheral oxygen saturation (SpO₂) will be measured with the same pulse oximeter at baseline, during injection, and post treatment, as an objective indicator of physiological stress or instability during the dental visit.
|
Baseline, during injection, and post treatment (approximately 20-30 minutes).
|
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Adverse events related to Melissa officinalis essential oil
Časové okno: 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).
|
All adverse events possibly related to exposure to Melissa officinalis essential oil (e.g., nausea, vomiting, dizziness, headache, respiratory symptoms, skin irritation, or other unexpected reactions) will be recorded throughout the visit. Serious adverse events will be documented and reported according to institutional and regulatory requirements. o Time |
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).
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- U.A.S.L.P. Estomatología
- NO FUNDING (Identifikátor registru: NO FUNDING)
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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