The Impact of Aromatherapy on Alleviating Dental Anxiety in Children

NCT ID: NCT06068777

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2022-08-21

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.

Conditions

Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

with no interference before dental anesthesia and extraction

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 Type: ACTIVE_COMPARATOR

Rosmary

Intervention Type: DRUG

inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar

Lemongrass group

children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar

Group Type: ACTIVE_COMPARATOR

Lemongrass Oil

Intervention Type: DRUG

inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.

Interventions

Rosmary

inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar

Intervention Type: DRUG

Lemongrass Oil

inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

faculty of dentistry Suez canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

455/2022

Identifier Type: -

Identifier Source: org_study_id