NCT06785480

Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if Computer Controlled Local Anesthetic Delivery (CCLAD) results in lower pain during local anesthesia administration for infiltration in the buccal region of the upper jaw in patients between 6 and 16 years old who will receive a dental treatment. The main questions it aims to answer are: * Does CCLAD result in lower self-reported pain (Visual Analogue Scale (VAS) and Face Pain Scale-Revised (FPS-R)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment? * Does CCLADD result in lower observed pain (Sound Eye Motor Scale (SEM)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment? * Does CCLAD result in lower hearth rate (HR) and galvanic skin response (GSR) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment? Researchers will compare CCLAD (Dentapen, Septodont, France) to conventional local anesthesia infiltration with a metallic syringe to see if the infiltration is less painful in patients between 6 and 16 years old who will receive a dental treatment. Participants will receive local anesthesia either with the Dentapen or metallic syringe. * GSR and heart rate are measured before anesthesia, during needle insertion, at 0.3 - 0.6 - 0.9ml, and after anesthesia. * Post-injection, the child provides VAS scores (if 8 years or older) and FPS-R (all patients). * A researcher not administering the injection determines the SEM score.

Conditions

• Local Anesthesia Injection Pain

Interventions

Type	Name	Description
DEVICE	Computer Controlled Local Anesthetic Delivery (CCLAD)	Administering local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline) with CCLAD. The CCLAD device is set to 60sec/ml in continuous mode.
DEVICE	Conventional metallic syringe	A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline).

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-01-25
• Completion: 2025-01-31
• First posted: 2025-01-21
• Last updated: 2025-04-15

Locations

1 site across 1 country: Belgium