Chamomile Gummies and Pediatric Dental Anxiety

Ain Shams University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Dental Anxiety

Treatments: Drug: chamomile gummy; Dietary Supplement: a multivitamin gummy

Study type: Interventional

Funder types: Other

Identifiers

NCT07138391

FDASU-Rec IR/052502

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

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).

Treatment:

Drug: chamomile gummy

The control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: a multivitamin gummy