Dental PhobiaCCLAD-PainNCT07056101
"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Children Undergoing Molar Extraction
A study testing A conventional dental syringe, GENI High-Speed Injection and GENI Moderate-Speed Injection in people with Dental Phobia and Dental Anxiety, run by Tarek MHD kher al saka amini at 1 site in Egypt.
Trial summary
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Phobia, Dental Anxiety, Dental Anesthesia
- What is being tested?
- A conventional dental syringe, GENI High-Speed Injection and GENI Moderate-Speed Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged from 6 to 8 years old
- Both sexes
- Healthy children classified as ASA I
- Children with maxillary primary molars indicated for extraction
- No previous dental experience
- Mentally capable of communication and following instructions
- No acute dental pain
Who cannot join
- Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
- Children with known allergies to the local anesthetic or dental materials used in the study
- Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
- Children whose parents or legal guardians refuse to sign the informed consent form
- Children experiencing acute dental pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Pain Perception Using Computer-Controlled Local Anaesthesia Delivery With Different Injection Speeds Versus Conventional Anaesthesia for Maxillary Primary Molars: A Randomized Controlled Trial
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.
Read the detailed description
This is a parallel-design randomized controlled clinical trial evaluating pain perception during local anesthesia administration in children undergoing extraction of maxillary primary molars. The study compares the use of a computer-controlled local anesthesia delivery system (GENI) at three different injection speeds-high, moderate, and low-with conventional syringe-based anesthesia.
Children aged 6 to 8 years who meet the inclusion criteria will be randomly allocated to one of four groups using a computer-generated randomization sequence. Standardized injection techniques will be applied in all groups. The primary outcome is subjective pain, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include objective behavioral pain assessments using the FLACC scale and physiological responses such as heart rate and oxygen saturation measured with a pulse oximeter.
All procedures will be performed by a single trained operator. The assistant supervisor will monitor randomization and data collection. Although blinding of the operator and participants is not feasible due to the nature of the devices, outcome assessors and the statistician will remain blinded to group assignment to reduce bias.
The study aims to identify whether the GENI device provides improved comfort, reduced pain, and greater cooperation among pediatric patients compared to traditional local anesthesia techniques. The results are expected to guide the development of better pain management strategies in pediatric dentistry.
- Being tested
- A conventional dental syringe, GENI High-Speed Injection, GENI Moderate-Speed Injection, GENI Low-Speed Injection
- Keywords
- GENI Device, Pain Perception, Local Anesthesia Technique, Articaine, Computer-Controlled Local Anesthesia, Dental Injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A conventional dental syringeDevice
The conventional dental syringe (C-K JECT) is a manual, metal aspirating syringe commonly used for local anesthesia administration in dental procedures. In this study, the device is used to perform buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. Injections are delivered manually at a standardized rate by the principal investigator. This arm serves as the active comparator to evaluate differences in pain perception between traditional syringe injections and those delivered via a computer-controlled device.
GENI High-Speed InjectionDevice
The GENI device is a computer-controlled local anesthesia delivery system that automates the injection process using pressure feedback to regulate flow. In this arm, the device is set to high-speed mode to deliver the anesthetic solution at the fastest available flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The procedure is carried out by the principal investigator using a standardized technique. Pain perception is assessed following injection to evaluate the impact of delivery speed on patient experience.
GENI Moderate-Speed InjectionDevice
The GENI device is a computer-controlled local anesthesia delivery system designed to regulate flow and pressure during injection using real-time feedback. In this arm, the device is set to moderate-speed mode, delivering anesthetic at an intermediate flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The injection is administered by the principal investigator using a standardized technique. This group is used to assess the impact of moderate-speed delivery on pain perception and physiological response in pediatric patients.
GENI Low-Speed InjectionDevice
The GENI device is a computer-controlled local anesthesia delivery system that maintains precise control over injection pressure and flow. In this arm, the device is set to low-speed mode, delivering the anesthetic solution at the slowest available rate to minimize tissue pressure and potential discomfort. Buccal and intrapapillary infiltration is administered using 4% articaine with 1:100,000 epinephrine. The injection is performed by the principal investigator using a standardized technique. This group evaluates whether low-speed delivery reduces pain perception and improves patient comfort compared to faster injection speeds and conventional methods.
| Study group | Role | What they receive |
|---|---|---|
| GENI High-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to high-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized technique. Pain perception will be evaluated immediately after injection. Receives: Device: GENI High-Speed Injection |
| GENI Moderate-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to moderate-speed injection mode. The injection will include buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. The procedure will be performed by the principal investigator using a standardized technique. Pain perception will be assessed immediately following the injection. Receives: Device: GENI Moderate-Speed Injection |
| GENI Low-Speed Injection | Experimental | Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to low-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized protocol. Pain perception will be evaluated using subjective, objective, and physiological measures. Receives: Device: GENI Low-Speed Injection |
| A Conventional dental Syringe | Active comparator | Participants in this arm will receive local anesthesia using a traditional metal aspirating dental syringe (C-K JECT) with a short 30-gauge needle. Buccal and intrapapillary infiltration will be performed using 4% articaine with 1:100,000 epinephrine, following a standardized injection technique. The procedure will be conducted by the principal investigator. Pain perception will be assessed immediately after the injection using subjective, objective, and physiological parameters. Receives: Device: A conventional dental syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
Pain perception will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). Each child will select the face that best represents their level of pain immediately following the injection. This scale is a validated tool for assessing subjective pain in pediatric patients.
Measured: Immediately after local anesthesia injection
Secondary outcomes (3)
Objective Pain Perception During local anathesia Injection (FLACC Scale)
Objective pain will be assessed using the FLACC Scale during the local anathesia injection . An external evaluator will observe and score facial expression,leg movement,activity,crying,and consolability.
Unit of measure :
Score (0-10)
Measured: During local anesthesia injection(Day 1)
Heart rate Response to Local Anesthesia injection
Heart rate will be measured using a fingertip pulse oximeter to evaluate physiological stress response. Reading will be taken before injection (baseline) and during the injection.
Unit of measure :
Beats per minute (bpm)
Measured: Baseline (within 10 minutes before injection )and during injection (Day 1)
Oxygen Saturation During Local Anesthesia injection
Oxygen saturation (%) will be measured using a fingertip pulse oximeter at baseline and during the injection to assess any change in oxygen levels as a physiological response to stress or pain.
Unit of measure :
Percentage (%)
Measured: Baseline (within 10 minutes before injection ) and during injection (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PhobiaStudies of the same condition, open and under way.
- 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
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: three receiving local anesthesia using the GENI computer-controlled device at different injection speeds (high, moderate, or low), and one receiving anesthesia via conventional syringe. Each participant will receive only one intervention throughout the study.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarek MHD kher al saka amini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarek MHD kher al saka amini, Cairo University
- Investigators
- Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056101
- Sponsor's protocol ID
- GENI-CCLAD VS CA
- Acronym
- CCLAD-Pain
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) that underlie the results reported in the final publication (text, tables, figures, and appendices) will be made available upon reasonable request. Access will be granted to researchers with a methodologically sound proposal for secondary analysis. Data will be available beginning 6 months after publication and ending 2 years after publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Perception Using Computer-Controlled Local Anaesthesia Delivery With Different Injection Speeds Versus Conventional Anaesthesia for Maxillary Primary Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07056101
- Acronym / sponsor ID
- CCLAD-Pain / GENI-CCLAD VS CA
- Keywords
- GENI Device, Pain Perception, Local Anesthesia Technique, Articaine, Computer-Controlled Local Anesthesia, Dental Injections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Tarek MHD kher al saka aminiUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Jul 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.
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.
Detailed description
This is a parallel-design randomized controlled clinical trial evaluating pain perception during local anesthesia administration in children undergoing extraction of maxillary primary molars. The study compares the use of a computer-controlled local anesthesia delivery system (GENI) at three different injection speeds-high, moderate, and low-with conventional syringe-based anesthesia.
Children aged 6 to 8 years who meet the inclusion criteria will be randomly allocated to one of four groups using a computer-generated randomization sequence. Standardized injection techniques will be applied in all groups. The primary outcome is subjective pain, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include objective behavioral pain assessments using the FLACC scale and physiological responses such as heart rate and oxygen saturation measured with a pulse oximeter.
All procedures will be performed by a single trained operator. The assistant supervisor will monitor randomization and data collection. Although blinding of the operator and participants is not feasible due to the nature of the devices, outcome assessors and the statistician will remain blinded to group assignment to reduce bias.
The study aims to identify whether the GENI device provides improved comfort, reduced pain, and greater cooperation among pediatric patients compared to traditional local anesthesia techniques. The results are expected to guide the development of better pain management strategies in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: three receiving local anesthesia using the GENI computer-controlled device at different injection speeds (high, moderate, or low), and one receiving anesthesia via conventional syringe. Each participant will receive only one intervention throughout the study.
| Arm | Type | Receives |
|---|---|---|
| GENI High-Speed Injection | Experimental | Device: GENI High-Speed InjectionParticipants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to high-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized technique. Pain perception will be evaluated immediately after injection. |
| GENI Moderate-Speed Injection | Experimental | Device: GENI Moderate-Speed InjectionParticipants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to moderate-speed injection mode. The injection will include buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. The procedure will be performed by the principal investigator using a standardized technique. Pain perception will be assessed immediately following the injection. |
| GENI Low-Speed Injection | Experimental | Device: GENI Low-Speed InjectionParticipants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to low-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized protocol. Pain perception will be evaluated using subjective, objective, and physiological measures. |
| A Conventional dental Syringe | Active comparator | Device: A conventional dental syringeParticipants in this arm will receive local anesthesia using a traditional metal aspirating dental syringe (C-K JECT) with a short 30-gauge needle. Buccal and intrapapillary infiltration will be performed using 4% articaine with 1:100,000 epinephrine, following a standardized injection technique. The procedure will be conducted by the principal investigator. Pain perception will be assessed immediately after the injection using subjective, objective, and physiological parameters. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged from 6 to 8 years old
- Both sexes
- Healthy children classified as ASA I
- Children with maxillary primary molars indicated for extraction
- No previous dental experience
Key exclusion criteria (5 listed)
- Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
- Children with known allergies to the local anesthetic or dental materials used in the study
- Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
- Children whose parents or legal guardians refuse to sign the informed consent form
- Children experiencing acute dental pain
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 |
|---|---|---|
| A conventional dental syringeThe conventional dental syringe (C-K JECT) is a manual, metal aspirating syringe commonly used for local anesthesia administration in dental procedures. In this study, the device is used to perform buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. Injections are delivered manually at a standardized rate by the principal investigator. This arm serves as the active comparator to evaluate differences in pain perception between traditional syringe injections and those delivered via a computer-controlled device. | Device | A Conventional dental Syringe |
| GENI High-Speed InjectionThe GENI device is a computer-controlled local anesthesia delivery system that automates the injection process using pressure feedback to regulate flow. In this arm, the device is set to high-speed mode to deliver the anesthetic solution at the fastest available flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The procedure is carried out by the principal investigator using a standardized technique. Pain perception is assessed following injection to evaluate the impact of delivery speed on patient experience. | Device | GENI High-Speed Injection |
| GENI Moderate-Speed InjectionThe GENI device is a computer-controlled local anesthesia delivery system designed to regulate flow and pressure during injection using real-time feedback. In this arm, the device is set to moderate-speed mode, delivering anesthetic at an intermediate flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The injection is administered by the principal investigator using a standardized technique. This group is used to assess the impact of moderate-speed delivery on pain perception and physiological response in pediatric patients. | Device | GENI Moderate-Speed Injection |
| GENI Low-Speed InjectionThe GENI device is a computer-controlled local anesthesia delivery system that maintains precise control over injection pressure and flow. In this arm, the device is set to low-speed mode, delivering the anesthetic solution at the slowest available rate to minimize tissue pressure and potential discomfort. Buccal and intrapapillary infiltration is administered using 4% articaine with 1:100,000 epinephrine. The injection is performed by the principal investigator using a standardized technique. This group evaluates whether low-speed delivery reduces pain perception and improves patient comfort compared to faster injection speeds and conventional methods. | Device | GENI Low-Speed Injection |
Primary outcome
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
Time frame: Immediately after local anesthesia injection
Pain perception will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). Each child will select the face that best represents their level of pain immediately following the injection. This scale is a validated tool for assessing subjective pain in pediatric patients.
3 secondary outcomes
Objective Pain Perception During local anathesia Injection (FLACC Scale)
Time frame: During local anesthesia injection(Day 1)
Heart rate Response to Local Anesthesia injection
Time frame: Baseline (within 10 minutes before injection )and during injection (Day 1)
Oxygen Saturation During Local Anesthesia injection
Time frame: Baseline (within 10 minutes before injection ) and during injection (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Official website of the Faculty of Dentistry at Cairo University, providing information about academic programs, research activities, and departmental contacts related to dental studies.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) that underlie the results reported in the final publication (text, tables, figures, and appendices) will be made available upon reasonable request. Access will be granted to researchers with a methodologically sound proposal for secondary analysis. Data will be available beginning 6 months after publication and ending 2 years after publication.
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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.
Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A conventional dental syringe, GENI High-Speed Injection and GENI Moderate-Speed Injection in people with Dental Phobia and Dental Anxiety, run by Tarek MHD kher al saka amini at 1 site in Egypt.
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 5 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: opening soon, as of the sponsor's last update on 14 Jul 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tarek MHD kher alsaka amini, Master degree (+201127255997, alsakatarek42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection (time frame: Immediately after local anesthesia injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.