Chamomile Gummies and Pediatric Dental Anxiety

NCT07138391 | Not Yet Recruiting Phase 2

• 1 other identifier: FDASU-Rec IR/052502
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety

Keywords

dental anxiety; chamomile; children

Outcome Measures

Primary Outcomes (3)

• Assessment of anxiety

  Anxiety assessments will be done using: 1\) 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.

  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

• Assessment of anxiety

  Anxiety assessments will be done using: 2\) Blood pressure: this will be measured using a digital blood pressure scale.

  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

• Assessment of anxiety

  Anxiety assessments will be done using: 3\) Modified Child Dental Anxiety Scale:

  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

Study Arms (2)

intervention group

EXPERIMENTAL

Participants in the intervention group will receive one chamomile gummy to chew approximately 30 minutes prior to their dental appointment. The gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA).

Drug: chamomile gummy

The control group

PLACEBO COMPARATOR

The control group will receive a multivitamin gummy, as a placebo, administered at the same time point (30 minutes prior to the appointment)

Dietary Supplement: a multivitamin gummy

Interventions

chamomile gummy DRUG

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

intervention group

a multivitamin gummy DIETARY_SUPPLEMENT

multivitamins gummies for kids

The control group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-shams university

Cairo, Egypt

Location

Central Study Contacts

Basma M Nagi, lecturer

CONTACT

00201026155509; basmamahmoud@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)