Not yet recruiting NCT07138391
Chamomile Gummies and Pediatric Dental Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chamomile gummy, a multivitamin gummy.
- Who it may be relevant to
- Registry conditions: Dental Anxiety. Basic parameters: 5 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Chamomile Gummies on Dental Anxiety in Children A Randomized Clinical Trial
Overview
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.
Interventions
- Drug chamomile gummy
The chamomile gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA). - Dietary supplement a multivitamin gummy
multivitamins gummies for kids
Primary outcome measures
- 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]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain-shams university — Cairo
Identifiers
NCT: NCT07138391 · FDASU-Rec IR/052502