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NOT YET RECRUITING
NCT07557160
NA

Dentapen® vs. Traditional Syringes for Child Dental Anxiety

Sponsor: Cairo University

View on ClinicalTrials.gov

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.

Official title: Child Anxiety During Administration of Anesthesia Delivered by Dentapen® Technique Versus Traditional Syringes Among a Group of Pediatric Dental Patients: Randomized Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-09-22

Completion Date

2026-12-14

Last Updated

2026-05-05

Healthy Volunteers

No

Interventions

DEVICE

Dentapen®

Cordless computer-controlled local anesthetic delivery (CCLAD) system (Septodont, Saint-Maur-des-Fossés, France). Uses ramp-up mode: slowest speed (1 mL/90 s) at maximum force with gradual flow over 5 seconds. Compatible with standard 1.7 mL anesthetic cartridges (4% articaine with 1:100,000 epinephrine) and disposable 30-gauge, 20 mm needles. Delivers buccal and intrapapillary infiltration for maxillary primary molar extraction.

DEVICE

Traditional Dental Syringe

Conventional side-loading stainless steel aspirating syringe (Medesy® 4957/1, Italy). Requires manual control of flow rate and pressure by the operator. Uses standard 1.7 mL anesthetic cartridges (4% articaine with 1:100,000 epinephrine) and disposable 30-gauge, 20 mm side-beveled needles. Delivers buccal and intrapapillary infiltration for maxillary primary molar extraction.