The Impact of Aromatherapy on Alleviating Dental Anxiety in Children

Sponsor

Suez Canal University (Other)

Overall Status

Completed

CT.gov ID

NCT06068777

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Syndrome	Drug: Rosmary Drug: Lemongrass Oil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 23, 2022

Actual Primary Completion Date :

Jul 23, 2022

Actual Study Completion Date :

Aug 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group with no interference before dental anesthesia and extraction
Active Comparator: Rosemary group children inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar,	Drug: Rosmary inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar
Active Comparator: Lemongrass group children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar	Drug: Lemongrass Oil inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.

Arm

Intervention/Treatment

No Intervention: Control group

with no interference before dental anesthesia and extraction

Active Comparator: Rosemary group

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

Drug: Rosmary

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

Active Comparator: Lemongrass group

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

Drug: Lemongrass Oil

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry Suez canal university	Ismailia		Egypt

Sponsors and Collaborators

Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suez Canal University

ClinicalTrials.gov Identifier:

NCT06068777

Other Study ID Numbers:

455/2022

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 5, 2023