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NCT Number: NCT07138391

Chamomile Gummies and Pediatric Dental Anxiety

The aim of this study is to evaluate the effect of oral chamomile on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate and blood pressure and by using modified child dental anxiety scale.

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Key information

Conditions

Dental Anxiety

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients exhibiting Frankl's behavior rating grade III or IV.
  • Children requiring invasive dental treatment in their primary teeth

Exclusion criteria

  • Patients with severe dental symptoms (e.g. spontaneous pain, pain not relieved by analgesics).
  • History of allergy to local anesthesia
  • Children who currently use any medication

Treatment and study plan

chamomile gummy

Drug

The chamomile gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA).

a multivitamin gummy

Dietary Supplement

multivitamins gummies for kids

Primary outcomes

  1. Assessment of anxiety

    Time frame: 1st measurement before gummy chewing and swallowing 2nd measurement 30 mins after gummy swallowing 3rd measurement after local anesthesia injection 4th measurement after completion of dental work one dental visit

    Anxiety assessments will be done using:

    • The pulse rate: Pulse rate will be measured using a finger-base type pulse oximeter (Beurer, Ulm, Germany). The children will be asked not to move their hand while the finger pulse oximeter is attached to their left index finger.

  2. Assessment of anxiety

    Time frame: 1st measurement before gummy chewing and swallowing 2nd measurement 30 mins after gummy swallowing 3rd measurement after local anesthesia injection 4th measurement after completion of dental work one dental visit

    Anxiety assessments will be done using:

    • Blood pressure: this will be measured using a digital blood pressure scale.

  3. Assessment of anxiety

    Time frame: 1st measurement before gummy chewing and swallowing 2nd measurement 30 mins after gummy swallowing 3rd measurement after local anesthesia injection 4th measurement after completion of dental work one dental visit

    Anxiety assessments will be done using:

    • Modified Child Dental Anxiety Scale:

Study contacts

Contact information is provided by the study sponsor or research team.

Basma M Nagi, lecturer

CONTACT

[email protected]

00201026155509

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Efficacy of Chamomile Gummies on Dental Anxiety in Children A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

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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