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

NCT07056101 | Not Yet Recruiting

• 1 other identifier: GENI-CCLAD VS CA
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

GENI Device; Pain Perception; Local Anesthesia Technique; Articaine; Computer-Controlled Local Anesthesia; Dental Injections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Objective Pain Perception During local anathesia Injection (FLACC Scale)

  During local anesthesia injection(Day 1)

• Heart rate Response to Local Anesthesia injection

  Baseline (within 10 minutes before injection )and during injection (Day 1)

• Oxygen Saturation During Local Anesthesia injection

  Baseline (within 10 minutes before injection ) and during injection (Day 1)

Study Arms (4)

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.

Device: GENI High-Speed 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.

Device: GENI Moderate-Speed 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.

Device: GENI Low-Speed Injection

A Conventional dental Syringe

ACTIVE COMPARATOR

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.

Device: A conventional dental syringe

Interventions

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.

A Conventional dental Syringe

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 High-Speed Injection

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 Moderate-Speed Injection

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.

GENI Low-Speed Injection

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarek MHD kher al saka amini: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 3755220, Egypt

Location

Related Links

• Official website of the Faculty of Dentistry at Cairo University, providing information about academic programs, research activities, and departmental contacts related to dental studies.

Study Officials

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

  Cairo University

  STUDY CHAIR

Central Study Contacts

tarek MHD kher alsaka amini, Master degree

CONTACT

+201127255997; alsakatarek42@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DOCTOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

EG (1)