Clinical trial NCT06068777: The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
Official title: Scentsational Smiles: The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dealing with dental anxiety in children is the most problematic responsibilities for pedodontists in the dental office. Essential oils had been used for reducing dental anxiety in adults; this study is a challenge to understand their effects on children. Aromatherapy is considered as a reasonable, potent, safe, and non-pharmacological way, which has been taken into consideration, especially for children who are supposed to go through any dental procedure under local anesthesia. The aim of this study is to explore and compare the effect of Rosemary versus Lemongrass essential oils on dental anxiety levels and vital signs of children during dental anesthesia and extraction of a lower primary molar in a dental office. Forty-five children, aged between 4 to 7 years, who had a minimum of one mandibular primary molar with deep caries indicated for extraction were selected. Patients are divided, randomly, into three groups (15 children each): Group I (control group): with no interference before dental anesthesia and extraction, Group II (Rosemary group): children inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar, Group III (Lemongrass group): children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar. Wong Baker Scale and the physiological measures of the children's anxiety will be evaluated and recorded for each child by measuring (pulse rate, oxygen saturation, and blood pressure) before, during and after the dental procedures.


Eligibility criteria: Inclusion Criteria:

* Patients aged from six to nine years old
* Both girls and boys will be included.
* Patients who need extraction in at least one primary molar.
* Parents who will agree to contribute in the study.
* Patients with Frankl Behavior Rating Scale, categories 2, 3 and 4

Exclusion Criteria:

* Medically compromised patient
* Allergic children

Primary outcomes:
measure: measuring pulse rate " heart rate"
timeFrame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
measure: oxygen saturation
timeFrame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
measure: blood pressure using a sphygmomanometer
timeFrame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
measure: pain level
timeFrame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: faculty of dentistry Suez canal university
Study officials:
References: