Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a parallel-design randomized controlled clinical trial evaluating pain perception during local anesthesia administration in children undergoing extraction of maxillary primary molars. The study compares the use of a computer-controlled local anesthesia delivery system (GENI) at three different injection speeds-high, moderate, and low-with conventional syringe-based anesthesia.
Children aged 6 to 8 years who meet the inclusion criteria will be randomly allocated to one of four groups using a computer-generated randomization sequence. Standardized injection techniques will be applied in all groups. The primary outcome is subjective pain, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include objective behavioral pain assessments using the FLACC scale and physiological responses such as heart rate and oxygen saturation measured with a pulse oximeter.
All procedures will be performed by a single trained operator. The assistant supervisor will monitor randomization and data collection. Although blinding of the operator and participants is not feasible due to the nature of the devices, outcome assessors and the statistician will remain blinded to group assignment to reduce bias.
The study aims to identify whether the GENI device provides improved comfort, reduced pain, and greater cooperation among pediatric patients compared to traditional local anesthesia techniques. The results are expected to guide the development of better pain management strategies in pediatric dentistry.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENI High-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to high-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized technique. Pain perception will be evaluated immediately after injection. |
|
| GENI Moderate-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to moderate-speed injection mode. The injection will include buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. The procedure will be performed by the principal investigator using a standardized technique. Pain perception will be assessed immediately following the injection. |
|
| GENI Low-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to low-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized protocol. Pain perception will be evaluated using subjective, objective, and physiological measures. |
|
| A Conventional dental Syringe |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A conventional dental syringe | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after local anesthesia injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During local anesthesia injection(Day 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| tarek MHD kher alsaka amini, Master degree | Contact | +201127255997 | alsakatarek42@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Giza Governorate | 3755220 | Egypt |
Not provided
| Label | URL |
|---|---|
| Official website of the Faculty of Dentistry at Cairo University, providing information about academic programs, research activities, and departmental contacts related to dental studies. | View source |
Not provided
De-identified individual participant data (IPD) that underlie the results reported in the final publication (text, tables, figures, and appendices) will be made available upon reasonable request. Access will be granted to researchers with a methodologically sound proposal for secondary analysis. Data will be available beginning 6 months after publication and ending 2 years after publication.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: three receiving local anesthesia using the GENI computer-controlled device at different injection speeds (high, moderate, or low), and one receiving anesthesia via conventional syringe. Each participant will receive only one intervention throughout the study.
Not provided
Not provided
Not provided
Not provided
Participants in this arm will receive local anesthesia using a traditional metal aspirating dental syringe (C-K JECT) with a short 30-gauge needle. Buccal and intrapapillary infiltration will be performed using 4% articaine with 1:100,000 epinephrine, following a standardized injection technique. The procedure will be conducted by the principal investigator. Pain perception will be assessed immediately after the injection using subjective, objective, and physiological parameters. |
|
|
| GENI High-Speed Injection | Device | 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. |
|
| GENI Moderate-Speed Injection | Device | 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. |
|
| GENI Low-Speed Injection | Device | 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. |
|
| 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) | Baseline (within 10 minutes before injection )and during injection (Day 1) |
| 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 (%) | Baseline (within 10 minutes before injection ) and during injection (Day 1) |