Decayed Primary MolarsNCT07915531
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
A study testing Cordless Electronic local anesthetic delivery system and Conventional dental syringe in people with Decayed Primary Molars, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
22 children with two primary molars that need extraction or pulpotomy will be selected to compare pain perception between conventional dental syringe and cordless electronic local anesthetic delivery system. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Primary Molars
- What is being tested?
- Cordless Electronic local anesthetic delivery system and Conventional dental syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2026to 1 Dec 2026
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Physically and mentally healthy children with no cognitive or emotional impairments.
- Having two contralateral primary molars need extraction or pulpotomy.
- No contraindication for the use of local anesthesia.
- Not taking any analgesic before the appointment for at least 24
Who cannot join
- History of allergy to local anesthetics
- acute infection or inflammation at the injection site,
- significant cognitive or developmental impairments that prevent reliable pain assessment
- use of analgesics or sedatives within 24 hours of the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Research Centre
Giza
National research centre NRC, 002+ 0233371615, info@nrc.sci.eg
About this study
Official title: Pain Perception Associated With Cordless Electronic Local Anesthetic Delivery System in Children
22 children with two primary molars that need extraction or pulpotomy will be selected to compare pain perception between conventional dental syringe and cordless electronic local anesthetic delivery system.
Read the detailed description
This is a split mouth randomized controlled trial, will be conducted in the outpatient clinic of pediatric dentistry, Medical and scientific Centre of Excellence, National Research Centre. and who have two primary molars that are indicated for pulpotomies or extractions. The study's protocol, risks, and benefits will be explained to the parents or legal guardians, and informed consent will be obtained from them if they agree to participate.
Clinical procedure:
- Explaining clinical procedure and the objectives of the study to parents or Guardians and obtaining an informed consent from them. the research will be conducted in conformity with the Declaration of Helsinki (2013).
- All children will be clinically examined and randomly assigned to one of the LA techniques (traditional or Star pen®) in the first appointment.
- Subjective evaluation of dental fear and anxiety of each child using The Dental Subscale of Children's Fear Survey Schedule (CFSS-DS) (Mobin et al., 2023)Prior any treatment.
- Subjective evaluation of pain perception will be evaluated for each child immediately post injection using Wong-Baker FACES Pain Rating Scale (WBFPRS) (Garra et al., 2010).
- Objective evaluation of pain behavior will be evaluated for each child during injection using FLACC Scale (Face, Legs, Activity, Cry, and Consolability) (Nagarwal et al., 2022).
- Physiological parameters of pain assessment such as Heart Rate and Oxygen saturation will be measured using pulse oximeter at pre-injection and during injection.
- Finishing the dental treatment either extraction or pulp therapy.
Statistical analysis:
Statistical analysis will be performed using a commercially available software program (SPSS Chicago, IL, USA).
Numerical data will be described as mean and standard deviation or as median and range as appropriate according to the normality of the data. Data will be compared using Mann Whitney U test or independent t test depending on normality.
The level of significance will be set at P≤0.05. All tests will be two tailed.
- Conditions
- Decayed Primary Molars
- Being tested
- Cordless Electronic local anesthetic delivery system, Conventional dental syringe
- Keywords
- CCLAD- Pain perception- Pain behavior- dental anesthesia- dental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordless Electronic local anesthetic delivery systemDevice
Wireless computer-controlled local anesthetic delivery (CCLADs) (Star Pen)with the control unit integrated into the syringe body, eliminating the need for foot pedal attachments. it uses use conventional dental needles and LA carpules
Conventional dental syringeDevice
The injection of a local anesthetic using conventional dental syringe
| Study group | Role | What they receive |
|---|---|---|
| Cordless Electronic Local anesthetic delivery system | Experimental | Not described Receives: Device: Cordless Electronic local anesthetic delivery system |
| Conventional dental Syringe | Active comparator | Not described Receives: Device: Conventional dental syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
assessment of pain perception between the two devices using Wong-Baker FACES Pain Rating Scale (WBFPRS), it consists of 6 faces with word descriptors and numbers from 0 to 10. The child is asked to point to the face that describes how he/she feels at the particular moment and numbers on this scale can be adjusted to a 0 to 10 Also FLACC Scale (Face, Legs, Activity, Cry, and Consolability) is used to assess behavioral pain of the child, it has scores from 0 to 2.
Measured: perioperative
Secondary outcomes (1)
Dental fear and anxiety
correlation between dental fear and anxiety and pain perception using Dental Subscale of Children's Fear Survey Schedule (CFSS-DS)
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start10 Aug 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed Primary MolarsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Mohamed Korayem, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915531
- Sponsor's protocol ID
- 29-7-2026
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception Associated With Cordless Electronic Local Anesthetic Delivery System in Children
- ClinicalTrials.gov ID
- NCT07915531
- Acronym / sponsor ID
- 29-7-2026
- Conditions
- Decayed Primary Molars
- Keywords
- CCLAD- Pain perception- Pain behavior- dental anesthesia- dental anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (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.
22 children with two primary molars that need extraction or pulpotomy will be selected to compare pain perception between conventional dental syringe and cordless electronic local anesthetic delivery system.
Detailed description
This is a split mouth randomized controlled trial, will be conducted in the outpatient clinic of pediatric dentistry, Medical and scientific Centre of Excellence, National Research Centre. and who have two primary molars that are indicated for pulpotomies or extractions. The study's protocol, risks, and benefits will be explained to the parents or legal guardians, and informed consent will be obtained from them if they agree to participate.
Clinical procedure:
- Explaining clinical procedure and the objectives of the study to parents or Guardians and obtaining an informed consent from them. the research will be conducted in conformity with the Declaration of Helsinki (2013).
- All children will be clinically examined and randomly assigned to one of the LA techniques (traditional or Star pen®) in the first appointment.
- Subjective evaluation of dental fear and anxiety of each child using The Dental Subscale of Children's Fear Survey Schedule (CFSS-DS) (Mobin et al., 2023)Prior any treatment.
- Subjective evaluation of pain perception will be evaluated for each child immediately post injection using Wong-Baker FACES Pain Rating Scale (WBFPRS) (Garra et al., 2010).
- Objective evaluation of pain behavior will be evaluated for each child during injection using FLACC Scale (Face, Legs, Activity, Cry, and Consolability) (Nagarwal et al., 2022).
- Physiological parameters of pain assessment such as Heart Rate and Oxygen saturation will be measured using pulse oximeter at pre-injection and during injection.
- Finishing the dental treatment either extraction or pulp therapy.
Statistical analysis:
Statistical analysis will be performed using a commercially available software program (SPSS Chicago, IL, USA).
Numerical data will be described as mean and standard deviation or as median and range as appropriate according to the normality of the data. Data will be compared using Mann Whitney U test or independent t test depending on normality.
The level of significance will be set at P≤0.05. All tests will be two tailed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cordless Electronic Local anesthetic delivery system | Experimental | Device: Cordless Electronic local anesthetic delivery system |
| Conventional dental Syringe | Active comparator | Device: Conventional dental syringe |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physically and mentally healthy children with no cognitive or emotional impairments.
- Having two contralateral primary molars need extraction or pulpotomy.
- No contraindication for the use of local anesthesia.
- Not taking any analgesic before the appointment for at least 24
Key exclusion criteria (4 listed)
- History of allergy to local anesthetics
- acute infection or inflammation at the injection site,
- significant cognitive or developmental impairments that prevent reliable pain assessment
- use of analgesics or sedatives within 24 hours of the procedure.
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 |
|---|---|---|
| Cordless Electronic local anesthetic delivery systemWireless computer-controlled local anesthetic delivery (CCLADs) (Star Pen)with the control unit integrated into the syringe body, eliminating the need for foot pedal attachments. it uses use conventional dental needles and LA carpules | Device | Cordless Electronic Local anesthetic delivery system |
| Conventional dental syringeThe injection of a local anesthetic using conventional dental syringe | Device | Conventional dental Syringe |
Primary outcome
Pain perception
Time frame: perioperative
assessment of pain perception between the two devices using Wong-Baker FACES Pain Rating Scale (WBFPRS), it consists of 6 faces with word descriptors and numbers from 0 to 10. The child is asked to point to the face that describes how he/she feels at the particular moment and numbers on this scale can be adjusted to a 0 to 10 Also FLACC Scale (Face, Legs, Activity, Cry, and Consolability) is used to assess behavioral pain of the child, it has scores from 0 to 2.
1 secondary outcome
Dental fear and anxiety
Time frame: perioperative
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordless Electronic local anesthetic delivery system and Conventional dental syringe in people with Decayed Primary Molars, run by National Research Centre, Egypt 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Eman A Korayem, Researcher (002+ 01282527959, ea.korayem@nrc.sci.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: perioperative). 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 4 Nov 2026.