NCT07101068

Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

Detailed description

This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe. The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy. Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design). To evaluate pain and anxiety, the following tools will be used: Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.

Conditions

• Dental Caries
• Reversible Pulpitis

Interventions

Type	Name	Description
DEVICE	Dental Anesthesia Injector	Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.
OTHER	conventional syringe	Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

2 sites across 1 country: Egypt