NCT07193342

Effect of Computer-controlled vs. Conventional Injection on Pain and Anxiety in Children

Comparison of Computer Controlled Automatic Injection Versus Conventional Injection Regarding Pain ,Anxiety and Child Behavior: "A Randomized Controlled Trial "

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children

Detailed description

This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels ) Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups : Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure. Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale . Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale. This study aims to determine whether Star pen® system offers a more comfortable and less anxiety - provoking experience for children compared to the conventional method. The result may guide pediatric dentists in selecting the most suitable delivery technique to improve the dental experience and cooperation in pediatric patients.

Conditions

• Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection

Interventions

Type	Name	Description
PROCEDURE	computer controlled automatic injection (Star pen® system)	local anesthesia will be administered using computer controlled automatic injection(Star pen® system ) to provide slow and consistent anesthetic flow, aiming to reduce pain and anxiety during pediatric dental treatment.
PROCEDURE	conventional anesthetic syringe	local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-10-15
• Completion: 2025-11-01
• First posted: 2025-09-25
• Last updated: 2025-11-19

Locations

1 site across 1 country: Egypt