Dentapen® vs. Traditional Syringes for Child Dental Anxiety

NCT07557160 | Not Yet Recruiting

• 1 other identifier: 181124
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Dental Anxiety; Local Anesthesia; Traditional Syringe; Primary Molar Extraction; Heart Rate; Computer-Controlled Local Anesthesia Delivery; Dentapen

Outcome Measures

Primary Outcomes (1)

• Child Anxiety

  Child anxiety assessed immediately after anesthetic injection and tooth extraction using the Wong-Baker Faces Scale (WBFS). The scale consists of six faces representing increasing levels of anxiety from 0 (no anxiety) to 10 (highest anxiety).

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

Secondary Outcomes (1)

• Heart Rate

  Baseline (immediately before anesthetic injection) and immediately after completion of anesthetic injection

Study Arms (2)

Dentapen® Technique

EXPERIMENTAL

Children in this arm receive local anesthesia using the Dentapen® (Septodont, France), a cordless computer-controlled local anesthetic delivery (CCLAD) system. The ramp-up mode is used to gradually initiate anesthetic flow. Anesthetic solution: 4% articaine with 1:100,000 epinephrine (Artpharma, Egypt) in a 1.7 mL cartridge. A 30-gauge, 20 mm short needle is used. Technique: buccal infiltration followed by intrapapillary infiltration into mesial and distal papillae. Heart rate is measured before and after injection using a pulse oximeter. Child anxiety is assessed immediately post-treatment using the Wong-Baker Faces Scale (WBFS). After confirming anesthesia (subjective patient report and objective dental probe testing), the maxillary primary molar is extracted with minimal trauma using luxation.

Device: Dentapen®

Traditional Syringe

ACTIVE COMPARATOR

Children in this arm receive local anesthesia using a conventional side-loading stainless steel aspirating syringe (Medesy® 4957/1, Italy). Anesthetic solution: 4% articaine with 1:100,000 epinephrine (Artpharma, Egypt) in a 1.7 mL cartridge. A 30-gauge, 20 mm short, side-beveled, sterile disposable needle is attached. Technique: buccal infiltration (needle bevel oriented toward bone, aspiration performed, solution deposited slowly over one minute) followed by intrapapillary infiltration (needle inserted 1-2 mm into mesial and distal papillae, solution injected slowly over one minute). Heart rate is measured before and after injection using a pulse oximeter. Child anxiety is assessed immediately post-treatment using the Wong-Baker Faces Scale (WBFS). After confirming anesthesia (subjective patient report and objective dental probe testing), the maxillary primary molar is extracted with minimal trauma using luxation.

Device: Traditional Dental Syringe

Interventions

Dentapen® DEVICE

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.

Dentapen® Technique

Traditional Dental Syringe DEVICE

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.

Traditional Syringe

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with medical, physical, or mental conditions.
• Children requiring emergency dental treatment (cellulitis, abscess).
• Children whose parents refuse to sign the informed consent.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were positioned supine with eyes closed during injection to prevent visualization of the device. Outcome assessors evaluated recorded videos where the injection site and the operator's hand holding the device were cropped. The statistician was also blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate at Pediatric dentistry department, Faculty of dentistry, Cairo University

Model Details: Participants are randomly assigned to one of two parallel groups: Dentapen® group or traditional syringe group in a 1:1 ratio.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): September 22, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share