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

Official title

Evaluation of Pain Perception Using Computer-Controlled Local Anaesthesia Delivery With Different Injection Speeds Versus Conventional Anaesthesia for Maxillary Primary Molars: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

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 t
• 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 followin
• 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 mod
• 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. T

Primary outcome measures

• Wong-Baker Subjective Pain Perception During Local Anesthesia Injection [Time frame: Immediately after local anesthesia injection]

Secondary outcome measures (3)

• Objective Pain Perception During local anathesia Injection (FLACC Scale) [Time frame: During local anesthesia injection(Day 1)]
• Heart rate Response to Local Anesthesia injection [Time frame: Baseline (within 10 minutes before injection )and during injection (Day 1)]
• Oxygen Saturation During Local Anesthesia injection [Time frame: Baseline (within 10 minutes before injection ) and during injection (Day 1)]

Eligibility criteria

Inclusion criteria

• Children aged from 6 to 8 years old
• Both sexes
• Healthy children classified as ASA I
• Children with maxillary primary molars indicated for extraction
• No previous dental experience
• Mentally capable of communication and following instructions
• No acute dental pain

Exclusion criteria

• 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
• Children experiencing acute dental pain

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo University — Cairo

Identifiers

NCT: NCT07056101 · GENI-CCLAD VS CA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗