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Completed

NCT Number: NCT06068777

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Suez canal university

Ismailia, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosmary

Drug

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

Lemongrass Oil

Drug

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

Primary outcomes

  1. measuring pulse rate " heart rate"

    Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

  2. oxygen saturation

    Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

    oxygen saturation using pulse oximeter.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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