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Dentapen® vs. Traditional Syringes for Child Dental Anxiety

NCT07557160 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Child Dental Anxiety

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-22
Primary Completion
2026-11-23
Completion
2026-12-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07557160 on ClinicalTrials.gov