Local Anesthesia Injection PainNCT06785480
Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial
A study testing Conventional metallic syringe in people with Local Anesthesia Injection Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia Injection Pain
- What is being tested?
- Conventional metallic syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- Computer Controlled Local Anesthetic Delivery (CCLAD), Conventional metallic syringe
- Keywords
- dentistry, pediatric, local anesthesia, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional metallic syringeDevice
A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional metallic syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after intervention, the child provides FPS-R scores.
Secondary outcomes (3)
Galvanic Skin Response (GSR)
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.
Measured: GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.
Heart rate (HR)
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start19 Oct 2022
- Primary completion25 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local Anesthesia Injection PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785480
- Sponsor's protocol ID
- BC-09243
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30143396
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial
- ClinicalTrials.gov ID
- NCT06785480
- Acronym / sponsor ID
- BC-09243
- Conditions
- Local Anesthesia Injection Pain
- Keywords
- dentistry, pediatric, local anesthesia, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| CCLAD | Experimental | Device: Computer Controlled Local Anesthetic Delivery (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. |
| Conventional syringe | Active comparator | Device: Conventional metallic syringeA 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | CCLAD |
| Conventional metallic syringeA conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline). | Device | Conventional syringe |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 30143396Patini 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.
- Individual participant dataSharing planned: No
Related trials for Local Anesthesia Injection Pain
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Recruiting
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
Rheumatological Injection, Pain Management
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional metallic syringe in people with Local Anesthesia Injection Pain, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Immediately after intervention, the child provides VAS scores.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06785480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.