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Clinical Trials/NCT06133868
NCT06133868Not yet recruitingNot Applicable

The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction

Cairo University0 sites60 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Anxiety

Study Overview

Brief Summary

The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction.

Detailed Description

Dental anxiety refers to an atypical and excessive fear of seeking dental care for preventative purposes or treatment, as well as an unreasonable level of anxiety in relation to dental operations. According to reports, dental anxiety frequently leads to elevated levels of caries and behavioral management difficulties in children. Furthermore, it has been observed that they exhibit impaired oral function and compromised oral esthetics. In the context of pediatric dentistry, several stimuli such as visual cues (e.g., needles), auditory cues (e.g., drilling sounds), olfactory cues (e.g., scents of cut dentin and eugenol), and tactile cues (e.g., high frequency vibrations) commonly contribute to the provoking of anxiety .

Aromatherapy is a form of complementary medicine where the use of essential oils has been found to contribute to the improvement of emotional well-being, the promotion of tranquillity, and the induction of relaxation in the human body . Aromatherapy has attracted interest in the dentistry area because to its alternative nature, since it is considered a possible method for preventative and analgesic purposes. This entails the application of vital aromatic compounds through the methods of inhalation, massage, or ingestion.

Lavender oil is widely recognized as a prominent fragrant oil within the field of aromatherapy, renowned for its anxiolytic properties The calming qualities of lavender oil have been historically acknowledged, making it a highly effective essential oil in the realm of aromatherapy. According to an article titled "Effect of Lavender Oil on Anxiety" it has been shown that lavender oil possesses stimulating properties on the parasympathetic system, leading to a subsequent decrease in both blood pressure and levels of anxiety. Multiple investigations have elucidated the existence of pharmacological actions with sedative properties, which exhibit dose-dependent characteristics. Furthermore, the incorporation of supplements exhibiting these benefits has recently been introduced into clinical practice .

Moreover, Kreidel et al., in 2021, suggested that lavender oil can be safely inhaled as a kind of aromatherapy, as no adverse effects have been reported. Therefore, the administration of lavender oil through inhalation is widely regarded as the most secure method among all available options. In their study. , it was determined that aromatherapy has the potential to serve as a non-aversive approach, wherein patients are exposed to pleasant aromas during dental procedures. Due to the favorable outcomes observed in medical contexts and among adult dental patients, a considerable number of dental professionals hold the belief that employing these methodologies could be efficacious in the treatment of children dental patients.

. Abd Alkhalek et al. (2023) examined the effects of lavender and orange essential oil inhalation on children's vital signs and anxiety during dental treatment. The study comprised 60 children who needed primary tooth extractions. Lavender, Orange, and Control oils were inhaled by the children. Before treatment, the patient's pulse, blood pressure, and oxygen saturation were checked. After the essential oil inhalation, anaesthetic, and extraction, measurements were taken. The Wong Baker Scale measured child anxiety. The Lavender and Orange groups showed a statistically significant reduction in anxiety levels after therapy, according to the Wong Packer Pain Scale. Heart rate and breathing rate also decreased. The experiments showed lavender outperformed orange.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Group I (Experimental group) Chamomile

Active Comparator
  • · Describing the method for the child to become familiar with

· The patient will inhale natural chamomile oil in a separate room prior to the intervention. Three drops (0.1 cc per drop) will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min.

Intervention: Lavender and Chamomile Essential Oils (Drug)

- Group II (Experimental group) Lavender

Active Comparator
  • Describing the method for the child to become familiar with.
  • The patient will inhale natural lavender oil (100% pure Lavandula) in a separate room prior to the intervention. Three drops (0.1 cc per drop) of lavender oil will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min

Intervention: Lavender and Chamomile Essential Oils (Drug)

- Group III (Control group) Cotton with saline

Placebo Comparator
  • Describing the method for the child to become familiar with
  • The patient will inhale a clear cotton roll with saline.

Intervention: Lavender and Chamomile Essential Oils (Drug)

Outcomes

Primary Outcomes

Anxiety

Time Frame: immediately after the intervention

Facial Image Scale (FIS) Score from (1-5) high score means worse outcome Score from (1-5) counting from left to right from 1 = not nervous at all to 5 = very very nervous

pain

Time Frame: immediately after the intervention

Faces, legs ,activity ,cry , and consolability Score (0-10) high score means worse outcome

Secondary Outcomes

  • Blood pressure (BP)(immediately after the intervention)
  • 3. Oxygen saturation(immediately after the intervention)
  • Pulse rate(immediately after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Ibrahim Mansour Elsherbini

principal investigator

Cairo University

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