Injection PainNCT07292194
Clinical Trial Comparing Pain Perception in Children Using Two Different Local Anesthesia Tools
A study testing super pen in people with Injection Pain and Local Anesthesia Infiltration, run by Lamis D. Rajab at 1 site in Jordan.
Trial summary
The goal of this clinical study is to learn whether the Super Pen (SP) device can reduce pain during local anesthesia (LA) infiltration for primary teeth compared to the conventional syringe (CS) in children aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Pain, Local Anesthesia Infiltration, Pediatric Patient
- What is being tested?
- super pen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2026to 1 Apr 2026
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who were 6-12 years of age, of both sexes.
- Children who were healthy and medically fit; ASA I .
- Children who had positive (Class 3) or definitely positive (Class 4) behavior during preoperative behavioral assessments according to the Frankl Scale at the enrollment visit.
- Children who require bilateral LA infiltration injections for primary teeth, either in the maxilla or mandible, for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
- Children with positive consent forms approved by their parents/ legal guardians.
Who cannot join
- Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures.
- Children with any mental, visual, or auditory impairment.
- Children who have medical or developmentally compromising conditions.
- Children who had developmental delay problems.
- Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
- Children who had active pathosis at the injection site that could affect anesthetic assessment.
- Patients who have negative (Class 2) or definitely negative (Class 1) behavior during preoperative behavioral assessments according to the Frankl Scale . - -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Experience in Pediatric Patients During Local Anesthesia Infiltration: A Split-Mouth Clinical Trial Comparing Super Pen And Traditional Syringe
The goal of this clinical study is to learn whether the Super Pen (SP) device can reduce pain during local anesthesia (LA) infiltration for primary teeth compared to the conventional syringe (CS) in children aged 6-12 years. It will also explore factors that influence children's pain perception and their preferences for the anesthesia delivery method.
The main questions this study aims to answer are:
Read more
- Does the Super Pen (SP) reduce the pain experienced during LA infiltration compared to the conventional syringe (CS)?
- How do factors such as age, sex, and arch treated (maxilla or mandible) influence children's pain perception when using the SP?
- Which method-SP or CS-do children prefer during LA infiltration?
Participants will:
Receive local anesthesia using both the SP and CS techniques in a split-mouth design.
Have their pain responses assessed using self-reported, behavioral, and physiological measures.
Indicate their preference for either technique after both experiences.
Read the detailed description
This clinical study aims to evaluate and compare the pain perception of pediatric patients aged 6-12 years during local anesthetic (LA) infiltration for primary teeth using the Computer-Controlled Local Anesthetic Delivery (CCLAD) system-Super Pen (SP)-versus the Conventional Syringe (CS) technique. The study follows a split-mouth crossover design, in which each child receives anesthesia using both techniques in separate appointments, allowing for direct within-subject comparison.
Pain assessment will be conducted using a combination of self-reported, behavioral, and physiological measures: the Faces Pain Scale-Revised (FPS-R), the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) behavioral pain scale, and heart rate monitoring. These multiple pain measures used provide a comprehensive evaluation of the child's pain experience.
The study will also investigate the influence of age, sex, and anatomical site (maxilla or mandible) on pain perception during SP administration. In addition, children's preferences for the two delivery systems (SP versus CS) will be recorded after both experiences to assess acceptance and comfort.
The findings of this research aim to contribute to improving pain management strategies in pediatric dentistry, supporting the use of more comfortable and child-friendly anesthesia delivery systems to enhance the dental experience and reduce anxiety in young patients.
- Being tested
- super pen
- Keywords
- clinical trial, split mouth, dental pain, local anesthesia device, local anesthesia infiltration
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
super penDevice
computer controlled local anesthesia delivery device
| Study group | Role | What they receive |
|---|---|---|
| Super Pen | Active comparator | Super Pen Computer-controlled Local Anesthesia delivery system Receives: Device: super pen |
| Conventional Syringe | No intervention | Conventional metal syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain using faces pain scale-revised (FPS-r)
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Measured: Immediately post-procedural (within 1 minute after completion of the local anesthetic injection)
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.
Measured: Periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
Physiological-Heart Rate
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
Measured: Baseline (5 minutes prior to local anesthetic injection) and periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection PainStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lamis D. Rajab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamis D. Rajab, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292194
- Sponsor's protocol ID
- UJordanLamis2
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Experience in Pediatric Patients During Local Anesthesia Infiltration: A Split-Mouth Clinical Trial Comparing Super Pen And Traditional Syringe
- ClinicalTrials.gov ID
- NCT07292194
- Acronym / sponsor ID
- UJordanLamis2
- Keywords
- clinical trial, split mouth, dental pain, local anesthesia device, local anesthesia infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Lamis D. RajabUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 18 Dec 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 study is to learn whether the Super Pen (SP) device can reduce pain during local anesthesia (LA) infiltration for primary teeth compared to the conventional syringe (CS) in children aged 6-12 years. It will also explore factors that influence children's pain perception and their preferences for the anesthesia delivery method.
The main questions this study aims to answer are:
- Does the Super Pen (SP) reduce the pain experienced during LA infiltration compared to the conventional syringe (CS)?
- How do factors such as age, sex, and arch treated (maxilla or mandible) influence children's pain perception when using the SP?
- Which method-SP or CS-do children prefer during LA infiltration?
Participants will:
Receive local anesthesia using both the SP and CS techniques in a split-mouth design.
Have their pain responses assessed using self-reported, behavioral, and physiological measures.
Indicate their preference for either technique after both experiences.
Detailed description
This clinical study aims to evaluate and compare the pain perception of pediatric patients aged 6-12 years during local anesthetic (LA) infiltration for primary teeth using the Computer-Controlled Local Anesthetic Delivery (CCLAD) system-Super Pen (SP)-versus the Conventional Syringe (CS) technique. The study follows a split-mouth crossover design, in which each child receives anesthesia using both techniques in separate appointments, allowing for direct within-subject comparison.
Pain assessment will be conducted using a combination of self-reported, behavioral, and physiological measures: the Faces Pain Scale-Revised (FPS-R), the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) behavioral pain scale, and heart rate monitoring. These multiple pain measures used provide a comprehensive evaluation of the child's pain experience.
The study will also investigate the influence of age, sex, and anatomical site (maxilla or mandible) on pain perception during SP administration. In addition, children's preferences for the two delivery systems (SP versus CS) will be recorded after both experiences to assess acceptance and comfort.
The findings of this research aim to contribute to improving pain management strategies in pediatric dentistry, supporting the use of more comfortable and child-friendly anesthesia delivery systems to enhance the dental experience and reduce anxiety in young patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Pen | Active comparator | Device: super penSuper Pen Computer-controlled Local Anesthesia delivery system |
| Conventional Syringe | No intervention | –Conventional metal syringe |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who were 6-12 years of age, of both sexes.
- Children who were healthy and medically fit; ASA I .
- Children who had positive (Class 3) or definitely positive (Class 4) behavior during preoperative behavioral assessments according to the Frankl Scale at the enrollment visit.
- Children who require bilateral LA infiltration injections for primary teeth, either in the maxilla or mandible, for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
- Children with positive consent forms approved by their parents/ legal guardians.
Key exclusion criteria (7 listed)
- Children who have had a history of unpleasant experiences in medical settings and/or LA injection procedures.
- Children with any mental, visual, or auditory impairment.
- Children who have medical or developmentally compromising conditions.
- Children who had developmental delay problems.
- Children with a history of chronic disease or use of medication that contraindicate the use of local anesthetics.
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 |
|---|---|---|
| super pencomputer controlled local anesthesia delivery device | Device | Super Pen |
Primary outcome
Self-reported pain using faces pain scale-revised (FPS-r)
Time frame: Immediately post-procedural (within 1 minute after completion of the local anesthetic injection)
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Time frame: Periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.
Physiological-Heart Rate
Time frame: Baseline (5 minutes prior to local anesthetic injection) and periprocedural (during local anesthetic injection, from needle insertion until completion of anesthetic delivery)
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
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 6 May 2026.
- Individual participant dataSharing planned: Yes
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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. 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 super pen in people with Injection Pain and Local Anesthesia Infiltration, run by Lamis D. Rajab at 1 site in Jordan.
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 5 inclusion and 7 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 6 May 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 Jordan. 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?
Self-reported pain using faces pain scale-revised (FPS-r) (time frame: Immediately post-procedural (within 1 minute after completion of the local anesthetic injection)). The study lists 3 primary outcomes in all. 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 6 May 2026.