Dental AnxietyPhase 4NCT07162272
The Efficacy of Melatonin Patches on Dental Anxiety in Children
A Phase 4 study testing Melatonin Patches in people with Dental Anxiety and Children, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of Problem: Dental anxiety significantly impacts dental treatment outcomes, particularly in pediatric patients. Given the side effects associated with current oral anxiolytic medications, there is a need to clinically evaluate safe and natural alternatives, such as melatonin patches, to validate their… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Children
- What is being tested?
- Melatonin Patches
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2025to 29 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 5-7 years old.
- 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 melatonin
- Children who currently use any medication
- Orphans and special health care needs patient.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of pediatric dentistry department faculty of Dentistry Ain Shams University
Cairo
About this study
Official title: The Efficacy of Melatonin Patches on Dental Anxiety in Children A Randomized Clinical Trial
Statement of Problem:
Dental anxiety significantly impacts dental treatment outcomes, particularly in pediatric patients. Given the side effects associated with current oral anxiolytic medications, there is a need to clinically evaluate safe and natural alternatives, such as melatonin patches, to validate their efficacy.
Read more
Aim of Study:
The aim of this study is to evaluate the effect of melatonin patches on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate, blood pressure, and by utilization of the modified child dental anxiety scale in pediatric dental patients.
Materials and Methods:
Fifty two children will be divided into two groups. One group (n=26) will be given two melatonin patches per patient and the other group (n=26) will receive two placebo stickers 30 minutes before dental treatment. Pulse rate, blood pressure and modified child dental anxiety scale will be recorded before and after dental treatment completion as well as after the intervention for both groups.
- Conditions
- Dental Anxiety, Children
- Being tested
- Melatonin Patches, Placebo Group
- Keywords
- Dental Anxiety, Children, Melatonin, Melatonin Patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin PatchesDrug
Also called Melatonin Stickers
Group 1 (n=26): Participants in the intervention group will receive two melatonin patches on their forearm (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before melatonin patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment.
Placebo GroupOther
Also called Non-melatonin patches, melatonin-free patches
Group 2 (n=26): Participants in the intervention group will receive two placebo patches on their forearm attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before placebo patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Melatonin Patch | Experimental | Group 1 (n=26): Participants in the intervention group will receive two melatonin patches (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their dental appointment according to the manufacturer's instructions. Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment. Receives: Drug: Melatonin Patches |
| Group 2: Placebo Group | Placebo comparator | Group 2 (n=26): The control group will receive two placebo stickers attached to the skin of their forearm at the same time point (30 minutes prior to the appointment). Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment. Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Child Dental Anxiety Scale
The child's anxiety will be measured using the five faces version of the modified child dental anxiety scale (MCDAS). It contains five-point Likert scale each corresponding to a smiley face that describe one of the feelings ranging from "relaxed/not worried" (1) to "very worried" (5). This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Measured: 1 day: from recruitment to end of treatment 1 day.
Blood Pressure
Measuring patients' systolic and diastolic blood pressure using a digital blood pressure scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Measured: 1 day: from recruitment to end of treatment 1 day.
Pulse rate
Measuring patients' pulse rate using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Measured: 1 day: from recruitment to end of treatment 1 day.
Oxygen Saturation
Measuring patients' oxygen saturation using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Measured: 1 day: from recruitment to end of treatment 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start25 Jun 2025
- Primary completion28 Aug 2025
- Study completion29 Aug 2025
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Wahba, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162272
- Sponsor's protocol ID
- 1512
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Melatonin Patches on Dental Anxiety in Children A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07162272
- Acronym / sponsor ID
- 1512
- Conditions
- Dental Anxiety, Children
- Keywords
- Dental Anxiety, Children, Melatonin, Melatonin Patches
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 9 Sep 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.
Statement of Problem:
Dental anxiety significantly impacts dental treatment outcomes, particularly in pediatric patients. Given the side effects associated with current oral anxiolytic medications, there is a need to clinically evaluate safe and natural alternatives, such as melatonin patches, to validate their efficacy.
Aim of Study:
The aim of this study is to evaluate the effect of melatonin patches on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate, blood pressure, and by utilization of the modified child dental anxiety scale in pediatric dental patients.
Materials and Methods:
Fifty two children will be divided into two groups. One group (n=26) will be given two melatonin patches per patient and the other group (n=26) will receive two placebo stickers 30 minutes before dental treatment. Pulse rate, blood pressure and modified child dental anxiety scale will be recorded before and after dental treatment completion as well as after the intervention for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Melatonin Patch | Experimental | Drug: Melatonin PatchesGroup 1 (n=26): Participants in the intervention group will receive two melatonin patches (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their dental appointment according to the manufacturer's instructions. Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment. |
| Group 2: Placebo Group | Placebo comparator | Other: Placebo GroupGroup 2 (n=26): The control group will receive two placebo stickers attached to the skin of their forearm at the same time point (30 minutes prior to the appointment). Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged 5-7 years old.
- Patients exhibiting Frankl's behavior rating grade III or IV.
- Children requiring invasive dental treatment in their primary teeth.
Key exclusion criteria (4 listed)
- Patients with severe dental symptoms (e.g. spontaneous pain, pain not relieved by analgesics).
- History of allergy to melatonin
- Children who currently use any medication
- Orphans and special health care needs patient.
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 |
|---|---|---|
| Melatonin PatchesAlso: Melatonin StickersGroup 1 (n=26): Participants in the intervention group will receive two melatonin patches on their forearm (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before melatonin patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment. | Drug | Group1: Melatonin Patch |
| Placebo GroupAlso: Non-melatonin patches, melatonin-free patchesGroup 2 (n=26): Participants in the intervention group will receive two placebo patches on their forearm attached to the skin of their forearm 30 minutes prior to their invasive dental treatment. Pulse Rate, Blood Pressure, and Modified Child Dental Anxiety Scale will be measured before placebo patches application, after 30minutes of patches application, then after local anesthesia injection, and finally after completing the invasive dental treatment. | Other | Group 2: Placebo Group |
Primary outcome
Modified Child Dental Anxiety Scale
Time frame: 1 day: from recruitment to end of treatment 1 day.
The child's anxiety will be measured using the five faces version of the modified child dental anxiety scale (MCDAS). It contains five-point Likert scale each corresponding to a smiley face that describe one of the feelings ranging from "relaxed/not worried" (1) to "very worried" (5). This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Blood Pressure
Time frame: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' systolic and diastolic blood pressure using a digital blood pressure scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Pulse rate
Time frame: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' pulse rate using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Oxygen Saturation
Time frame: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' oxygen saturation using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin Patches in people with Dental Anxiety and Children, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Nov 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Child Dental Anxiety Scale (time frame: 1 day: from recruitment to end of treatment 1 day.). The study lists 4 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 13 Nov 2025.