Dental AnxietyPhase 2/3NCT07138391
Chamomile Gummies and Pediatric Dental Anxiety
A Phase 2/3 study testing chamomile gummy and a multivitamin gummy in people with Dental Anxiety, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- chamomile gummy and a multivitamin gummy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Nov 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients exhibiting Frankl's behavior rating grade III or IV.
- Children requiring invasive dental treatment in their primary teeth
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain-shams university
Cairo
vice dean for graduate studies and research affairs, 20222639088, viced.research@dent.asu.edu.eg
About this study
Official title: The Efficacy of Chamomile Gummies on Dental Anxiety in Children A Randomized Clinical 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.
- Conditions
- Dental Anxiety
- Being tested
- chamomile gummy, a multivitamin gummy
- Keywords
- dental anxiety, chamomile, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chamomile gummyDrug
The chamomile gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA).
a multivitamin gummyDietary supplement
multivitamins gummies for kids
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Dietary Supplement: a multivitamin gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of anxiety
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.
Measured: 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:
- Blood pressure: this will be measured using a digital blood pressure scale.
Measured: 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:
- Modified Child Dental Anxiety Scale:
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138391
- Sponsor's protocol ID
- FDASU-Rec IR/052502
- Status last verified
- Jun 2025
- First submitted
- 5 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Chamomile Gummies on Dental Anxiety in Children A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07138391
- Acronym / sponsor ID
- FDASU-Rec IR/052502
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, chamomile, children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: chamomile gummyParticipants 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). |
| The control group | Placebo comparator | Dietary Supplement: a multivitamin gummyThe control group will receive a multivitamin gummy, as a placebo, administered at the same time point (30 minutes prior to the appointment) |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients exhibiting Frankl's behavior rating grade III or IV.
- Children requiring invasive dental treatment in their primary teeth
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chamomile gummyThe chamomile gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA). | Drug | intervention group |
| a multivitamin gummymultivitamins gummies for kids | Dietary supplement | The control group |
Primary outcome
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: 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.
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: 2) Blood pressure: this will be measured using a digital blood pressure scale.
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: 3) Modified Child Dental Anxiety Scale:
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing chamomile gummy and a multivitamin gummy in people with Dental Anxiety, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basma M Nagi, lecturer (00201026155509, basmamahmoud@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.