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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Local Anesthesia Injection Pain

Treatments: Device: Computer Controlled Local Anesthetic Delivery (CCLAD); Device: Conventional metallic syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT06785480

BC-09243

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

CCLAD

Experimental group

Description:

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.

Treatment:

Device: Computer Controlled Local Anesthetic Delivery (CCLAD)

Conventional syringe

Active Comparator group

Description:

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.

Treatment:

Device: Conventional metallic syringe