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
2 other identifiers
interventional
45
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2026
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 18, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2027
Study Completion
Last participant's last visit for all outcomes
February 25, 2027
May 18, 2026
May 1, 2026
7 months
May 11, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in dental anxiety (MCDASf score)
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).
Secondary Outcomes (5)
Observed pain during needle insertion (SEM scale)
During needle insertion and anesthetic injection (approximately 1-2 minutes).
Self reported pain after treatment (Wong-Baker Faces)
Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).
Heart rate during dental treatment
Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).
Oxygen saturation during dental treatment
Baseline, during injection, and post treatment (approximately 20-30 minutes).
Adverse events related to Melissa officinalis essential oil
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).
Study Arms (3)
Aromatherapy with Melissa officinalis essential oil - Brand A
EXPERIMENTALChildren 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.
Aromatherapy with Melissa officinalis essential oil - Brand B
EXPERIMENTALChildren 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.
Standard behavioral management
ACTIVE COMPARATORChildren 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 39697190BACKGROUNDNirmala 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: 34849354BACKGROUNDRigillo 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: 41007011BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Due to the olfactory nature of the intervention, blinding of operators and participants is not feasible. Therefore, only the principal investigator and the outcome assessor will be blinded to group allocation. The operator performing the dental procedures and managing the aromatherapy device will be aware of the assigned intervention, due to the practical characteristics of the olfactory exposure. However, the individuals responsible for data analysis and for evaluating anxiety, pain, and physiological outcomes will not know which intervention each child received, in order to minimize assessment bias.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 18, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
January 10, 2027
Study Completion (Estimated)
February 25, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05