[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638249":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":42,"locations":41,"responsibleParty":51,"collaborators":41,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":41,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":82,"whyStopped":41,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":41},{"fullName":5,"class":6},"Universidad Autonoma de San Luis Potosí","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nA 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.",[13],"Other: Aromatherapy with Melissa officinalis essential oil - Brand A",{"label":15,"type":10,"description":16,"interventionNames":17},"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.\n\nThe 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.",[18],"Other: Aromatherapy with Melissa officinalis essential oil - Brand B",{"label":20,"type":21,"description":22,"interventionNames":23},"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.\n\nWithout 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.",[24],"Other: Standard behavioral management",[26,31,36],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"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.",[9],[30],"Aromatherapy A",{"type":6,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[15],[35],"Aromatherapy B",{"type":6,"name":20,"description":37,"armGroupLabels":38,"otherNames":39},"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.",[20],[40],"Child behavioral control",null,[43,48],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},"Dhira Limón-Ramírez, DDS","CONTACT","52 1 844 196 05 15","dhiraramirez0@gmail.com",{"name":49,"role":45,"phone":50,"phoneExt":41,"email":41},"Miguel Rosales-Berber, M.Sc,","+52 1 444 131 8166",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","José Arturo Garrocho Rangel","Clinical Professor","100638249","phase-2-melissa-officinalis-aromatherapy-for-dental-anxiety-in-children-100638249",false,"NCT07592130","Melissa Officinalis Aromatherapy for Dental Anxiety in Children","Anxiolytic Effect of Inhaled Melissa Officinalis Essential Oil During Mandibular Local Anesthesia in Pediatric Dental Patients: A Randomized Controlled Clinical Trial","No acronym","Inclusion Criteria:\n\n* Children aged 6 to 10 years at the time of enrollment.\n* Male or female pediatric patients in good general physical and mental health.\n* Require mandibular local anesthesia (inferior alveolar nerve block) for pulpotomy or pulpectomy of at least one primary molar.\n* No previous experience with dental local anesthesia.\n* Behavior classified as \"positive\" or \"negative but accepting\" (categories 2 or 3) according to the Frankl Behavior Rating Scale during the initial examination.\n* Ability of the child to understand simple verbal instructions appropriate for age.\n* Parent or legal guardian able and willing to sign written informed consent.\n* Child willing to provide verbal assent to participate in the study.\n\nExclusion Criteria:\n\n* History of previous dental local anesthesia.\n* Presence of dental emergencies (e.g., acute infection, severe pain, or swelling) requiring urgent treatment.\n* Known diagnosis of neurological, psychiatric, developmental, or behavioral disorders that may interfere with cooperation or with the assessment of anxiety and pain.\n* 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.\n* Current acute upper respiratory conditions, such as common cold, rhinitis, sinusitis, or nasal allergy that could alter the sense of smell or breathing comfort.\n* Known allergy, hypersensitivity, or adverse reaction to Melissa officinalis, other Lamiaceae plants, essential oils, or components of the products used in the study.\n* Use of anxiolytics, antidepressants, sedatives, or other psychotropic medications within the last 30 days.\n* Behavior rated as definitely negative (Frankl category 1) or definitely positive (Frankl category 4) at baseline.\n* Inability of parents or guardians to understand the study information or provide informed consent.\n* Participation in another clinical trial within the previous 30 days.","ALL","6 Years","10 Years",{"count":67,"type":68},45,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","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.\n\nThe 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.",[74,75],"Emotional Anxiety and Stress During Pediatric Dental Treatment","Dental Anesthesia",[77,78,79,80,81],"Pediatric dental anxiety","Aromatherapy","PediMelissa officinalis","Essential oils","Pediatric oral anesthesia","NOT_YET_RECRUITING","2026-05-11",{"date":85,"type":86},"2026-05-18","ACTUAL",{"date":88,"type":68},"2026-06-15",{"date":90,"type":68},"2027-02-25",{"name":5,"class":6}]