Clinical trial NCT06785480: Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial
Official title: Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia Injection Pain
Keywords: dentistry
pediatric
local anesthesia
pain
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Immediately after intervention, the child provides VAS scores.
measure: Face Pain Scale-Revised (FPS-R)
timeFrame: Immediately after intervention, the child provides FPS-R scores.
Secondary outcomes:
measure: Galvanic Skin Response (GSR)
timeFrame: GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
measure: Heart rate (HR)
timeFrame: Heart rate is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
measure: Sound Eye Motor Scale (SEM)
timeFrame: 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.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent university hospital
state: East-Flanders
Study officials:
References:
citation: 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.