"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Children Undergoing Molar Extraction

Summary

This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.

Conditions

• Dental Phobia
• Dental Anxiety
• Dental Anesthesia
• Dental Anesthesia Efficacy

Interventions

DEVICE

A conventional dental syringe

The conventional dental syringe (C-K JECT) is a manual, metal aspirating syringe commonly used for local anesthesia administration in dental procedures. In this study, the device is used to perform buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. Injections are delivered manually at a standardized rate by the principal investigator. This arm serves as the active comparator to evaluate differences in pain perception between traditional syringe injections and those delivered via a computer-controlled device.

DEVICE

GENI High-Speed Injection

The GENI device is a computer-controlled local anesthesia delivery system that automates the injection process using pressure feedback to regulate flow. In this arm, the device is set to high-speed mode to deliver the anesthetic solution at the fastest available flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The procedure is carried out by the principal investigator using a standardized technique. Pain perception is assessed following injection to evaluate the impact of delivery speed on patient experience.

DEVICE

GENI Moderate-Speed Injection

The GENI device is a computer-controlled local anesthesia delivery system designed to regulate flow and pressure during injection using real-time feedback. In this arm, the device is set to moderate-speed mode, delivering anesthetic at an intermediate flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The injection is administered by the principal investigator using a standardized technique. This group is used to assess the impact of moderate-speed delivery on pain perception and physiological response in pediatric patients.

DEVICE

GENI Low-Speed Injection

The GENI device is a computer-controlled local anesthesia delivery system that maintains precise control over injection pressure and flow. In this arm, the device is set to low-speed mode, delivering the anesthetic solution at the slowest available rate to minimize tissue pressure and potential discomfort. Buccal and intrapapillary infiltration is administered using 4% articaine with 1:100,000 epinephrine. The injection is performed by the principal investigator using a standardized technique. This group evaluates whether low-speed delivery reduces pain perception and improves patient comfort compared to faster injection speeds and conventional methods.

Sponsors & Collaborators

• Tarek MHD kher al saka amini

  lead OTHER

Principal Investigators

• Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-10-15

Completion

2025-10-31

Countries

• Egypt