Clinical Trial

Dentapen® vs. Traditional Syringes for Child Dental Anxiety

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-27.
Trial Details
NCT Number NCT07557160
Lead Sponsor Cairo University
Conditions Child Dental Anxiety
Enrollment 42 participants
Start Date 2026-09-22
Primary Completion 2026-11-23 (estimated)
Study Completion 2026-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-05-05