An interventional study of computer controlled automatic injection (Star pen® system) and conventional anesthetic syringe in Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
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
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's enrollment of 48 is below the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.
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Inclusion criteria:
Parental consent and child assent required for enrollment.
- Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device).
Procedure: computer controlled automatic injection (Star pen® system)
Children will receive local anesthesia using a conventional dental syringe.
Procedure: conventional anesthetic syringe
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.
local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.
Simplified Faces Pain Scale
Time frame: Immediately after injection procedure
Sound, eye, motor scale
Time frame: Starting From point entry of anesthesia till end of injection procedure
pulse oximeter
Time frame: From sitting of patient on dental chair till the end of the injection procedure
Venham Behavior Rating Scale
Time frame: Starting From point of entry of anesthesia till end of injection procedure
Plan to share: No — No individual participant data will be shared
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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