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.
Children aged from 6 to 8 years old
Both sexes
Healthy children classified as ASA I
Children with maxillary primary molars indicated for extraction
Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
Children with known allergies to the local anesthetic or dental materials used in the study
Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
Children whose parents or legal guardians refuse to sign the informed consent form
Parallel
A conventional dental syringe
DeviceThe 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.
GENI High-Speed Injection
DeviceThe 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.
GENI Moderate-Speed Injection
DeviceThe 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.
GENI Low-Speed Injection
DeviceThe 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.
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
Pain perception will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). Each child will select the face that best represents their level of pain immediately following the injection. This scale is a validated tool for assessing subjective pain in pediatric patients.
Objective Pain Perception During local anathesia Injection (FLACC Scale)
Objective pain will be assessed using the FLACC Scale during the local anathesia injection . An external evaluator will observe and score facial expression,leg movement,activity,crying,and consolability. Unit of measure : Score (0-10)
Heart rate Response to Local Anesthesia injection
Heart rate will be measured using a fingertip pulse oximeter to evaluate physiological stress response. Reading will be taken before injection (baseline) and during the injection. Unit of measure : Beats per minute (bpm)
Oxygen Saturation During Local Anesthesia injection
Oxygen saturation (%) will be measured using a fingertip pulse oximeter at baseline and during the injection to assess any change in oxygen levels as a physiological response to stress or pain. Unit of measure : Percentage (%)
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Tarek MHD kher al saka amini
Lead sponsor
Cairo University
Sponsor institution
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