About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients exhibiting Frankl's behavior rating grade III or IV.

Children requiring invasive dental treatment in their primary teeth

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

78 Participants

are divided into 2 treatment groups

Group A: intervention groupExperimental treatment 1 intervention

Group B: The control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

2

Assessment of anxiety

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

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

3

Assessment of anxiety

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

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

Chamomile Gummies and Pediatric Dental Anxiety

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts