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

NCT ID: NCT07193342

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

computer controlled automatic injection ( Star pen® system)

Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device).

Group Type: EXPERIMENTAL

computer controlled automatic injection (Star pen® system)

Intervention Type: PROCEDURE

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.

conventional anesthetic syringe

Children will receive local anesthesia using a conventional dental syringe.

Group Type: ACTIVE_COMPARATOR

conventional anesthetic syringe

Intervention Type: PROCEDURE

local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.

Interventions

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.

Intervention Type: PROCEDURE

conventional anesthetic syringe

local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Nouran Negm ElDin Mahmoud

Master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Future University in Egypt

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

PEDI_INJ_TRIAL2025

Identifier Type: -

Identifier Source: org_study_id