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

Tarek MHD kher al saka amini

Status: Not yet enrolling

Conditions: Dental Anxiety; Dental Anesthesia Efficacy; Dental Phobia; Dental Anesthesia

Treatments: Device: GENI High-Speed Injection; Device: GENI Low-Speed Injection; Device: GENI Moderate-Speed Injection; Device: A conventional dental syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT07056101

GENI-CCLAD VS CA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

GENI High-Speed Injection

Experimental group

Description:

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.

Treatment:

Device: GENI High-Speed Injection

GENI Moderate-Speed Injection

Experimental group

Description:

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.

Treatment:

Device: GENI Moderate-Speed Injection

GENI Low-Speed Injection

Experimental group

Description:

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.

Treatment:

Device: GENI Low-Speed Injection

A Conventional dental Syringe

Active Comparator group

Description:

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.

Treatment:

Device: A conventional dental syringe