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

April 14, 2025 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East-Flanders
      • Gent, East-Flanders, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Patients between the ages of 6 and 16 years
  • Requiring a buccal injection with local anesthesia for dental treatment, bilaterally in the upper jaw
  • Treatments: restorative filing, pulpotomy, extraction or a steel crown placement
  • At least one week between both treatments
  • Complying with the criteria of ASA I (ASA classification of The American Society of Anaesthesiologists, 1963)
  • Fluent in Dutch
  • Children who had a score of 3 or higher on the Frankl scale

Exclusion criteria:

  • Contraindications to inject Local anesthesia (allergy to the liquid, ...)
  • Patients referred because of needle phobia or behavior management problems
  • Refusing to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCLAD
The CCLAD device is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline). It is set to 60sec/ml in continuous mode. All participants receive this intervention on one randomly assigned side of the mouth.
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.
Active Comparator: Conventional syringe
A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline). All participants receive this intervention on one randomly assigned side of the mouth.
Device: Conventional metallic syringe
A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Immediately after intervention, the child provides VAS scores.
The Visual Analog Scale is a self-report pain assessment tool applicable from the age of eight. The scale is a 100mm line, where 'no pain' is on the left and 'severe pain' is on the right. Patients indicate the level of pain experienced during local anesthesia by marking this scale. The scale is generally interpretted as follows: 0-4 mm (0-0.4): No pain or mild pain; 5-44 mm (0.5-4.4): Mild pain; 45-74 mm (4.5-7.4): Moderate pain; 75-100 mm (7.5-10): Severe pain. A higher score thus means a worse outcome.
Immediately after intervention, the child provides VAS scores.
Face Pain Scale-Revised (FPS-R)
Time Frame: Immediately after intervention, the child provides FPS-R scores.
The Face Pain Scale-Revised (FPS-R) is a self-report pain measurement tool. The scale consists of six gender neutral faces devoid of smiles or tears. Each face corresponds to a score ranging from zero to ten, with only the even numbers used. It is important to employ appropriate language while utilizing the FPS-R. You can use short phrases like 'this face means no pain' or 'this face means very much pain', avoiding the terms 'happy' and 'sad'. In this study the Face Pain Scale-Revised will be used from the age of six. The specific scores for each face from left to right are: 0, 2, 4, 6, 8, 10. A higher score means a worse outcome.
Immediately after intervention, the child provides FPS-R scores.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Galvanic Skin Response (GSR)
Time Frame: GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
The Galvanic Skin Response, also known as the psychogalvanic Reflex, is used to measure the stress reaction. During local anesthesia, individuals commonly undergo a stress response, triggering an elevation in sympathetic activity. The rise in sympathetic tone activates the sweat glands. As a result, the resistance of the skin decreases, and the electrical conduction increases. To measure these changes, two electrodes are placed, one on the index finger and the other on the middle finger, and these are linked to the application "Mindfield eSense". A higher Galvanic Skin Response is correlated to higher stress and thus a worse outcome.
GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
Heart rate (HR)
Time Frame: Heart rate is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
Stress and anxiety trigger the autonomic nervous system. This acts on the parasympathetic system, which is suppressed, and the sympathetic system, which is activated. Due to activation of the sympathetic system epinephrine and norepinephrine are released from the adrenal glands. The release of these hormones causes vasoconstriction in the blood vessels, increased blood pressure and increased heart rate. In this study, the heart rate will be measured with a pulse oximeter. A higher heart rate is a worse outcome.
Heart rate is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
Sound Eye Motor Scale (SEM)
Time Frame: A researcher not administering the injection determines the SEM score periprocedurally, from the start of injection until 1,2 minutes later when the injection has been completed.
The Sound Eye Motor (SEM) scale is used to assess children's responses during local anesthesia. Three parameters are considered: sound, eyes and motor skills. Each parameter is divided into 4 categories: comfort, mild comfort, moderate discomfort and severe discomfort, with corresponding scores from 1 to 4. The total score is derived by adding up the scores from these parameters, with a maximum possible score of 12 and a minimum of 3. A higher score is a worse outcome.
A researcher not administering the injection determines the SEM score periprocedurally, from the start of injection until 1,2 minutes later when the injection has been completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

January 25, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-09243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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