Not Yet RecruitingNot Applicable

Dentapen® vs. Traditional Syringes for Child Dental Anxiety

42 participantsStarted 2026-09-22

Plain-language summary

This study aims to compare two different methods of giving local anesthesia (numbing medicine) to children during dental treatment. The two methods are: Dentapen® - a computer-controlled, pen-like device that delivers the numbing medicine slowly and steadily. Traditional syringe - the standard metal syringe commonly used in dental clinics. The main question is: Does using the Dentapen® device reduce child anxiety during the injection compared to the traditional syringe? The study will include children aged 6-8 years who need to have an upper primary (baby) molar tooth extracted. The child's heart rate will be measured before and after the injection, and the child's anxiety level will be assessed immediately after treatment using the Wong-Baker Faces Scale (a picture scale showing different levels of worry or fear). Participants will be randomly assigned (like flipping a coin) to receive the injection either with the Dentapen® or with the traditional syringe. Neither the child nor the person measuring the outcomes will know which device was used. The dentist giving the injection cannot be blinded because the devices look different.

Who can participate

Age range

6 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged between 6 and 8 years. * Cooperative children. * Children having normal intellectual development. * Children willing to provide assent and parent willing to provide informed consent. * Healthy children with no systemic problems according to parental history. * First dental visit. * Children with bilaterally maxillary primary molars indicated for extraction. Exclusion Criteria: * Children with medical, physical, or mental conditions. * Children requiring emergency dental treatment (cellulitis, abscess). * Children whose parents refuse to sign the informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child Anxiety

Timeframe: Immediately after treatment (within 5 minutes of completing anesthetic injection and extraction)

Trial details

NCT IDNCT07557160

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-23

View on ClinicalTrials.gov More Child Dental Anxiety trials