Emotional Anxiety and Stress During Pediatric Dental TreatmentPhase 2No acronymNCT07592130
Melissa Officinalis Aromatherapy for Dental Anxiety in Children
A Phase 2 study testing Aromatherapy with Melissa officinalis essential oil - Brand A, Aromatherapy with Melissa officinalis essential oil - Brand B and Standard behavioral management in people with Emotional Anxiety and Stress During Pediatric Dental Treatment and Dental Anesthesia, run by Universidad Autonoma de San Luis Potosí.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Emotional Anxiety and Stress During Pediatric Dental Treatment, Dental Anesthesia
- What is being tested?
- Aromatherapy with Melissa officinalis essential oil - Brand A, Aromatherapy with Melissa officinalis essential oil - Brand B and Standard behavioral management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 25 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Miguel Rosales-Berber, M.Sc, contact
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Aromatherapy with Melissa officinalis essential oil - Brand A, Aromatherapy with Melissa officinalis essential oil - Brand B, Standard behavioral management
- Keywords
- Pediatric dental anxiety, Aromatherapy, PediMelissa officinalis, Essential oils, Pediatric oral anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy with Melissa officinalis essential oil - Brand AOther
Also called Aromatherapy 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.
Aromatherapy with Melissa officinalis essential oil - Brand BOther
Also called Aromatherapy 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.
Standard behavioral managementOther
Also called Child behavioral control
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.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy with Melissa officinalis essential oil - Brand A | Experimental | 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. Receives: Other: Aromatherapy with Melissa officinalis essential oil - Brand A |
| Aromatherapy with Melissa officinalis essential oil - Brand B | Experimental | 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. Receives: Other: Aromatherapy with Melissa officinalis essential oil - Brand B |
| Standard behavioral management | Active comparator | 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. Receives: Other: Standard behavioral management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: During needle insertion and anesthetic injection (approximately 1-2 minutes).
Self reported pain after treatment (Wong-Baker Faces)
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.
Measured: Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).
Heart rate during dental treatment
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.
Measured: Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).
Oxygen saturation during dental treatment
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.
Measured: Baseline, during injection, and post treatment (approximately 20-30 minutes).
Adverse events related to Melissa officinalis essential oil
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.
- Time
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emotional Anxiety and Stress During Pediatric Dental TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592130
- Sponsor's protocol ID
- U.A.S.L.P. Estomatología
- Other IDs
- No funding
- Acronym
- No acronym
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined whether individual participant data (IPD) collected in this study will be made available to other researchers. The decision will depend on institutional policies, ethical committee recommendations, and future data-sharing agreements established after completion of the study.
Publications
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.
PubMed 39697190Nirmala 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.
PubMed 34849354Rigillo 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.
PubMed 41007011
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiolytic Effect of Inhaled Melissa Officinalis Essential Oil During Mandibular Local Anesthesia in Pediatric Dental Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07592130
- Acronym / sponsor ID
- No acronym / U.A.S.L.P. Estomatología
- Keywords
- Pediatric dental anxiety, Aromatherapy, PediMelissa officinalis, Essential oils, Pediatric oral anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy with Melissa officinalis essential oil - Brand A | Experimental | Other: Aromatherapy with Melissa officinalis essential oil - Brand AChildren 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 | Experimental | Other: Aromatherapy with Melissa officinalis essential oil - Brand BChildren 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 comparator | Other: Standard behavioral managementChildren 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy with Melissa officinalis essential oil - Brand AAlso: Aromatherapy AMelissa 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 A |
| Aromatherapy with Melissa officinalis essential oil - Brand BAlso: Aromatherapy BMelissa 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 | Aromatherapy with Melissa officinalis essential oil - Brand B |
| Standard behavioral managementAlso: Child behavioral controlBehavioral 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. | Other | Standard behavioral management |
Primary outcome
Change in dental anxiety (MCDASf score)
Time frame: 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.
5 secondary outcomes
Observed pain during needle insertion (SEM scale)
Time frame: During needle insertion and anesthetic injection (approximately 1-2 minutes).
Self reported pain after treatment (Wong-Baker Faces)
Time frame: Immediately after completion of pulpotomy or pulpectomy (within 5-10 minutes).
Heart rate during dental treatment
Time frame: Baseline, during injection, and post treatment (total monitoring period approximately 20-30 minutes).
Oxygen saturation during dental treatment
Time frame: Baseline, during injection, and post treatment (approximately 20-30 minutes).
Adverse events related to Melissa officinalis essential oil
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 39697190Yadav 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.
- Background: PubMed 34849354Nirmala 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.
- Background: PubMed 41007011Rigillo 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.
- Individual participant dataSharing planned: Undecided. It has not yet been determined whether individual participant data (IPD) collected in this study will be made available to other researchers. The decision will depend on institutional policies, ethical committee recommendations, and future data-sharing agreements established after completion of the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Rosales-Berber, M.Sc, contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aromatherapy with Melissa officinalis essential oil - Brand A, Aromatherapy with Melissa officinalis essential oil - Brand B and Standard behavioral management in people with Emotional Anxiety and Stress During Pediatric Dental Treatment and Dental Anesthesia, run by Universidad Autonoma de San Luis Potosí.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dhira Limón-Ramírez, DDS (52 1 844 196 05 15, dhiraramirez0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dental anxiety (MCDASf score) (time frame: From baseline before the dental appointment to immediately after local anesthetic injection (approximately 15-20 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07592130, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.