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NCT Number: NCT07193342

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

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

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Key information

Conditions

Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, Cairo Governorate, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

conventional anesthetic syringe

Procedure

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

Primary outcomes

  1. Simplified Faces Pain Scale

    Time frame: Immediately after injection procedure

  2. Sound, eye, motor scale

    Time frame: Starting From point entry of anesthesia till end of injection procedure

Secondary outcomes

  1. pulse oximeter

    Time frame: From sitting of patient on dental chair till the end of the injection procedure

  2. Venham Behavior Rating Scale

    Time frame: Starting From point of entry of anesthesia till end of injection procedure

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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