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临床试验/NCT06068777
NCT06068777已完成不适用

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

Suez Canal University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
pain level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Medically compromised patient
  • Allergic children

研究组 & 干预措施

Rosemary group

Active Comparator

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

干预措施: Rosmary (Drug)

Lemongrass group

Active Comparator

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

干预措施: Lemongrass Oil (Drug)

结局指标

主要结局

pain level

时间窗: 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

measuring pulse rate " heart rate"

时间窗: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

blood pressure using a sphygmomanometer

时间窗: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

systolic and diastolic blood pressure will be measured

oxygen saturation

时间窗: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"

oxygen saturation using pulse oximeter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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