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

NCT06785480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-04-15

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2025-01-25
Completion
2025-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06785480 on ClinicalTrials.gov