The Impact of Aromatherapy on Alleviating Dental Anxiety in Children

Pain Syndrome Clinical Trial

Official title:

Scentsational Smiles: The Impact of Aromatherapy on Alleviating Dental Anxiety in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068777
• Other study ID #: 455/2022
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: August 21, 2022

Study information

• Verified date: September 2023
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 21, 2022
• Est. primary completion date: July 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Syndrome

Intervention

Drug:
• Rosmary
inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar
• Lemongrass Oil
inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.

Locations

Country	Name	City	State
Egypt	faculty of dentistry Suez canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring pulse rate " heart rate"		baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
Primary	oxygen saturation	oxygen saturation using pulse oximeter.	baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
Primary	blood pressure using a sphygmomanometer	systolic and diastolic blood pressure will be measured	baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
Primary	pain level	the Wong-Baker Scale will be used where 0 no pain and 7 hurts worst	baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"