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

NCT07193342 | Completed

• 1 other identifier: PEDI_INJ_TRIAL2025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

dental pain; behavior management; local anesthesia in children; pediatric dentistry

Outcome Measures

Primary Outcomes (2)

• Simplified Faces Pain Scale

  Immediately after injection procedure

• Sound, eye, motor scale

  Starting From point entry of anesthesia till end of injection procedure

Secondary Outcomes (2)

• 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

Study Arms (2)

computer controlled automatic injection ( Star pen® system)

EXPERIMENTAL

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

Procedure: computer controlled automatic injection (Star pen® system)

conventional anesthetic syringe

ACTIVE COMPARATOR

Children will receive local anesthesia using a conventional dental syringe.

Procedure: conventional anesthetic syringe

Interventions

computer controlled automatic injection (Star pen® system) 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.

computer controlled automatic injection ( Star pen® system)

conventional anesthetic syringe PROCEDURE

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

conventional anesthetic syringe

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)