Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental InjectionNCT07193342
Effect of Computer-controlled vs. Conventional Injection on Pain and Anxiety in Children
A study testing conventional anesthetic syringe in people with Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection
- What is being tested?
- conventional anesthetic syringe
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Nov 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 6-9 years.
- Participants are required to undergo dental procedures requiring local infiltration anesthesia.
- Only cooperative patients (scoring 3 or 4 on the Frankl Behavior Scale).
- No prior dental experiences.
- Patients need maxillary infiltration anesthesia.
- No prior symptoms of abscess.
Show all 12Show fewer
- Only children with ASA I health status (Free from developmental or systemic disorders).
- Parental consent and child assent required for enrollment.
- Exclusion criteria:
- Medical conditions or systemic illnesses.
- Psychiatric conditions affecting pain or anxiety evaluation.
- Parental refusal or child unwillingness to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Computer Controlled Automatic Injection Versus Conventional Injection Regarding Pain ,Anxiety and Child Behavior: "A Randomized Controlled Trial "
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children
Read the detailed description
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels )
Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups :
Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure.
Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale .
Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale.
This study aims to determine whether Star pen® system offers a more comfortable and less anxiety - provoking experience for children compared to the conventional method. The result may guide pediatric dentists in selecting the most suitable delivery technique to improve the dental experience and cooperation in pediatric patients.
- Being tested
- computer controlled automatic injection (Star pen® system), conventional anesthetic syringe
- Keywords
- dental pain, behavior management, local anesthesia in children, pediatric dentistry
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer controlled automatic injection (Star pen® system)Procedure or surgery
local anesthesia will be administered using computer controlled automatic injection(Star pen® system ) to provide slow and consistent anesthetic flow, aiming to reduce pain and anxiety during pediatric dental treatment.
conventional anesthetic syringeProcedure or surgery
local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.
| Study group | Role | What they receive |
|---|---|---|
| computer controlled automatic injection ( Star pen® system) | Experimental | Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device). Receives: Procedure: computer controlled automatic injection (Star pen® system) |
| conventional anesthetic syringe | Active comparator | Children will receive local anesthesia using a conventional dental syringe. Receives: Procedure: conventional anesthetic syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Faces Pain Scale
Measured: Immediately after injection procedure
Sound, eye, motor scale
Measured: Starting From point entry of anesthesia till end of injection procedure
Secondary outcomes (2)
pulse oximeter
Measured: From sitting of patient on dental chair till the end of the injection procedure
Venham Behavior Rating Scale
Measured: Starting From point of entry of anesthesia till end of injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Sep 2025
- Primary completion15 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental InjectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Negm ElDin Mahmoud, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193342
- Sponsor's protocol ID
- PEDI_INJ_TRIAL2025
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer Controlled Automatic Injection Versus Conventional Injection Regarding Pain ,Anxiety and Child Behavior: "A Randomized Controlled Trial "
- ClinicalTrials.gov ID
- NCT07193342
- Acronym / sponsor ID
- PEDI_INJ_TRIAL2025
- Keywords
- dental pain, behavior management, local anesthesia in children, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 25 Sep 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 randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children
Detailed description
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels )
Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups :
Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure.
Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale .
Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale.
This study aims to determine whether Star pen® system offers a more comfortable and less anxiety - provoking experience for children compared to the conventional method. The result may guide pediatric dentists in selecting the most suitable delivery technique to improve the dental experience and cooperation in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer controlled automatic injection ( Star pen® system) | Experimental | Procedure: computer controlled automatic injection (Star pen® system)Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device). |
| conventional anesthetic syringe | Active comparator | Procedure: conventional anesthetic syringeChildren will receive local anesthesia using a conventional dental syringe. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Pediatric patients aged 6-9 years.
- Participants are required to undergo dental procedures requiring local infiltration anesthesia.
- Only cooperative patients (scoring 3 or 4 on the Frankl Behavior Scale).
- No prior dental experiences.
- Patients need maxillary infiltration anesthesia.
Key exclusion criteria (0 listed)
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 automatic injection (Star pen® system)local anesthesia will be administered using computer controlled automatic injection(Star pen® system ) to provide slow and consistent anesthetic flow, aiming to reduce pain and anxiety during pediatric dental treatment. | Procedure or surgery | computer controlled automatic injection ( Star pen® system) |
| conventional anesthetic syringelocal anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients. | Procedure or surgery | conventional anesthetic syringe |
Primary outcome
Simplified Faces Pain Scale
Time frame: Immediately after injection procedure
Sound, eye, motor scale
Time frame: Starting From point entry of anesthesia till end of injection procedure
2 secondary outcomes
pulse oximeter
Time frame: From sitting of patient on dental chair till the end of the injection procedure
Venham Behavior Rating Scale
Time frame: Starting From point of entry of anesthesia till end of injection procedure
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 19 Nov 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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 anesthetic syringe in people with Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection, run by Future University in 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 12 inclusion and 0 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 19 Nov 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?
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?
Simplified Faces Pain Scale (time frame: Immediately after injection procedure). 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?
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 19 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.