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

Future University in Egypt

Status: Completed

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

Treatments: Procedure: computer controlled automatic injection (Star pen® system); Procedure: conventional anesthetic syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT07193342

PEDI_INJ_TRIAL2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

computer controlled automatic injection ( Star pen® system)

Experimental group

Description:

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

Treatment:

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

conventional anesthetic syringe

Active Comparator group

Description:

Children will receive local anesthesia using a conventional dental syringe.

Treatment:

Procedure: conventional anesthetic syringe