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

NCT06785480 | Completed

• 1 other identifier: BC-09243
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dentistry; pediatric; local anesthesia; pain

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  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)

  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 Outcomes (3)

• Galvanic Skin Response (GSR)

  GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.

• Heart rate (HR)

  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)

  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.

Study Arms (2)

CCLAD

EXPERIMENTAL

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)

Conventional syringe

ACTIVE COMPARATOR

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

Interventions

Computer Controlled Local Anesthetic Delivery (CCLAD) DEVICE

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.

CCLAD

Conventional metallic syringe DEVICE

A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline).

Conventional syringe

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent university hospital

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (1)

• Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.

  PMID: 30143396 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split Mouth Design In this randomized controlled study, each patient undergoes two separate dental treatments, bilateral in the upper jaw. Each patient will receive local anesthesia once administered using the CCLAD device and another time using the conventional syringe. There is at least on week in between the two treatments. This study design effectively employs each patient as their own control, allowing for a direct within-person comparison of the two anesthesia delivery methods The participants are randomized through block randomization for type of local anesthesia and starting side of the mouth (left or right).

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 21, 2025
• Study Start: October 19, 2022
• Primary Completion: January 25, 2025
• Study Completion: January 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)