Evaluation of Computer-controlled Local Anesthesia in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Local Anesthesia Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Computer Controlled Local Anesthetic Delivery (CCLAD)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Conventional metallic syringe

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Conventional metallic syringe

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes