AzTrials
AzTrials

Anxiety, DentalNCT06133868

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

A study testing Lavender and Chamomile Essential Oils in people with Anxiety, Dental, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Dental
What is being tested?
Lavender and Chamomile Essential Oils
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

The inclusion criteria:

  1. Patients with primary a mandibular molar that needs to be extracted.
  2. Patients aged between 6 and 12 years.
  3. Patients in their first dental visit.
  4. Patients who are intellectually sufficient to complete the anxiety scale.
  5. Children category 2, 3, 4 according to the Frankl Behaviour Rating Scale.
  6. Patients whose parents were willing to participate in the study.

The exclusion criteria:

  1. Patients with common allergies; Paediatric dental local anaesthesia allergies should be excluded to prevent bad reactions. Dental professionals should know how to treat local anaesthetic side effects such allergic and toxic responses. Consider the patient's medical history and physical condition before choosing a local anaesthetic dose and type. Identifying latex allergy patients and avoiding latex-containing products during dental operations is also important. For paediatric dental operations to be safe and effective, individuals with dental local anaesthesia allergies must be excluded.
  2. Patients with respiratory tract infections or lung diseases; There is a potential increased susceptibility for paediatric patients to experience unfavourable respiratory tract effects following exposure to essential oils such as lavender and chamomile. The literature has demonstrated that upon inhalation, essential oils has the ability to effectively penetrate both the upper and lower regions of the respiratory tract
  3. Patients with systemic problems; Lavender and chamomile essential oils may cause side effects in children with systemic diseases including impaired immune systems or chronic illnesses. Epidemiological studies have revealed no link between lavender essential oils and endocrine disturbance in youngsters. Children routinely exposed to these essential oils have similar endocrine abnormalities as those who are not .

Trial locations and contacts

No sites are listed yet.

Sara Ibrahim El Sherbini, master contact

+201022922040

sara.mansour@dentistry.cu.edu.eg

Reem wahby, phd contact

reem.wahby@dentistry.cu.edu.eg

About this study

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

Read the 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.

Chamomile is a further medicinal plant employed in the practice of aromatherapy . Chamomile essential oil, derived from the herbaceous plant belonging to the Asteraceae family, is one of the several oils that can be effectively used in the practice of inhalation aromatherapy. Apigenin, a chemical included in chamomile, demonstrates the capacity to interact with gamma-aminobutyric acid (GABA) receptors, potentially resulting in sedative and anti-anxiety effects. Chamomile also functions by stimulating the release of cortisol, has been found to alleviate anxiety. Previous studies have investigated the effects of this essential oil in various therapeutic contexts. A recent investigation carried out by (Ebrahimi et al., 2022) revealed the potential advantages associated with the use of chamomile essential oil aromatherapy in the reduction of anxiety levels among individuals having esophagogastroduodenoscopy. Additionally, this intervention was found to alleviate sensations of sorrow and improve the quality of sleep experienced by these patients. Currently, there is a lack of scholarly investigation about the concurrent utilization of lavender and chamomile essential oils by inhalation and its effects on reducing anxiety and pain in the field of pediatric dentistry.

Interestingly; The guidelines set forth by the American Academy of Pediatric Dentistry (AAPD) in 2023 suggest the utilization of aromatherapy as a non-pharmacological approach for alleviating anxiety and pain. Recommendations for Oral Health Policies The concept of endorsements refers to the act of publicly expressing support or approval for a person, According to Resources (The Reference Manual of Pediatric Dentistry 2022-2023 Definitions Oral Health Policies Recommendations Endorsements Resources, n.d.), the effectiveness and analgesic properties of lavender and chamomile oils have been the subject of previous research; yet, the majority of studies have mostly focused on adult populations. To the best of our current understanding, this research represents the inaugural investigation into the utilization of lavender oil inhalation as a means to examine the potential relationship between anxiety levels and vital signs in youngsters undergoing a stressful surgical dental intervention

Conditions
Anxiety, Dental
Being tested
Lavender and Chamomile Essential Oils
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lavender and Chamomile Essential OilsDrug

    essential oils

Study groups in NCT06133868
Study groupRoleWhat they receive
Group I (Experimental group) ChamomileActive 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.
Receives: Drug: Lavender and Chamomile Essential Oils
- Group II (Experimental group) LavenderActive 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
Receives: Drug: Lavender and Chamomile Essential Oils
- Group III (Control group) Cotton with salinePlacebo comparator* Describing the method for the child to become familiar with * The patient will inhale a clear cotton roll with saline.
Receives: Drug: Lavender and Chamomile Essential Oils

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety

    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

    Measured: immediately after the intervention

  2. pain

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

    Measured: immediately after the intervention

Secondary outcomes (3)
  1. Blood pressure (BP)

    Sphygmomanometer

    mmHg

    Measured: immediately after the intervention

  2. Pulse rate

    Manual Beat/min

    Measured: immediately after the intervention

  3. 3. Oxygen saturation

    Pulse oximeter Percentage (%)

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133868
Sponsor's protocol ID
Lavander vs chamomile
Status last verified
Nov 2023
First submitted
9 Nov 2023
Last updated
18 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ebrahimi H, Mardani A, Basirinezhad MH, Hamidzadeh A, Eskandari F. The effects of Lavender and Chamomile essential oil inhalation aromatherapy on depression, anxiety and stress in older community-dwelling people: A randomized controlled trial. Explore (NY). 2022 May-Jun;18(3):272-278. doi: 10.1016/j.explore.2020.12.012. Epub 2021 Jan 9.

    PubMed 33454232

Questions about this trial

What is this clinical trial studying?

A study testing Lavender and Chamomile Essential Oils in people with Anxiety, Dental, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Ibrahim El Sherbini, master (+201022922040, sara.mansour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06133868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in