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 "

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

Study Overview

• Status: Completed
• Conditions: Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection
• Intervention / Treatment: Procedure: computer controlled automatic injection (Star pen® system); Procedure: conventional anesthetic syringe

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11835
      • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Pediatric patients aged 6-9 years.
• Participants are required to undergo dental procedures requiring local infiltration anesthesia.
• Only cooperative patients (scoring 3 or 4 on the Frankl Behavior Scale).
• No prior dental experiences.
• Patients need maxillary infiltration anesthesia.
• No prior symptoms of abscess.
• Only children with ASA I health status (Free from developmental or systemic disorders).

• Parental consent and child assent required for enrollment.

  - Exclusion criteria:

• Medical conditions or systemic illnesses.
• Psychiatric conditions affecting pain or anxiety evaluation.
• Parental refusal or child unwillingness to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: computer controlled automatic injection ( Star pen® system); Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device).	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.
Active Comparator: conventional anesthetic syringe; Children will receive local anesthesia using a conventional dental syringe.	Procedure: conventional anesthetic syringe; local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Simplified Faces Pain Scale	Immediately after injection procedure
Sound, eye, motor scale	Starting From point entry of anesthesia till end of injection procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
pulse oximeter	From sitting of patient on dental chair till the end of the injection procedure
Venham Behavior Rating Scale	Starting From point of entry of anesthesia till end of injection procedure

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: August 17, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Estimated): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: dental pain; behavior management; pediatric dentistry; local anesthesia in children
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Toothache
• Other Study ID Numbers: PEDI_INJ_TRIAL2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No