The Impact of Aromatherapy on Alleviating Dental Anxiety in Children

September 28, 2023 updated by: Suez Canal University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Faculty of Dentistry Suez canal university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring pulse rate " heart rate"
Time Frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
oxygen saturation
Time Frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
oxygen saturation using pulse oximeter.
baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
blood pressure using a sphygmomanometer
Time Frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
systolic and diastolic blood pressure will be measured
baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
pain level
Time Frame: 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
baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Actual)

July 23, 2022

Study Completion (Actual)

August 21, 2022

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 455/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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