Pain Perception of the New DeviceNCT07156032
Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
A study testing Starpen automatic injection device and conventional syringe in people with Pain Perception of the New Device, run by Cairo University.
Trial summary
To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Pain Perception of the New Device
- What is being tested?
- Starpen automatic injection device and conventional syringe
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-8 years
- Cooperative children ( rating 3 or 4 based on the Frankl behavior scale )
- Medically fit children (ASA I )
- Children mentally capable of communication
- First dental visit
- Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies
- No acute dental pain
Who cannot join
- Children with a behavioral management problem
- Parental refusal of participation
- Children with previous history of local anesthesia injection
- Medically unfit children (other than ASA I )
- Uncooperative children ( other than Frankl 3,4)
- Children under medications ( antibiotics and analgesics ) for the previous 48 hours that could alter the pain perception
- Teeth that showed any signs of mobility , ankylosis or root resorption affecting more than one third the root
- Acute dental pain
About this study
Official title: Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial
To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.
Read the detailed description
After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.
- Conditions
- Pain Perception of the New Device
- Being tested
- Starpen automatic injection device, conventional syringe
- Keywords
- Starpen device, Computer controlled automatic injection device, Computer controlled injection, pain perception, infiltration anesthesia, extraction of maxillary primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starpen automatic injection deviceDevice
Also called computer controlled injection device
Starpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle
conventional syringeProcedure or surgery
Also called dental syringe
injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle
| Study group | Role | What they receive |
|---|---|---|
| Starpen automatic injection device | Experimental | effect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars Receives: Device: Starpen automatic injection device |
| Conventional syringe | Active comparator | Conventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars Receives: Procedure: conventional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain during injection
Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.
Measured: during procedure
Secondary outcomes (5)
Objective pain during infiltration
Objective pain perception during infiltration anesthesia using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.
Measured: during procedure
Subjective pain during extraction
Subjective pain perception during extraction of maxillary primary molars using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.
Measured: during procedure
Objective pain during extraction
Objective pain perception during extraction of maxillary primary molars using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.
Measured: during procedure
Physiological parameters ( heart rate )
Physiological parameters ( heart rate) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 70-100 bpm is the normal range at rest and higher heart rate readings reflects anxiety/pain/ discomfort .
Measured: Readings will be taken before and during anesthesia injection and during extraction.
Physiological parameter ( oxygen saturation)
Physiological parameter ( oxygen saturation) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 95-100% is the normal range on room air . A drop below 94% indicates hypoxemia and immediate assessment must be for airway and breathing.
Measured: Readings will be taken before and during anesthesia injection and during extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Perception of the New DeviceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Mohamed Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156032
- Sponsor's protocol ID
- SPen device injection in MPM
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07156032
- Acronym / sponsor ID
- SPen device injection in MPM
- Conditions
- Pain Perception of the New Device
- Keywords
- Starpen device, Computer controlled automatic injection device, Computer controlled injection, pain perception, infiltration anesthesia, extraction of maxillary primary molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 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.
To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.
Detailed description
After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starpen automatic injection device | Experimental | Device: Starpen automatic injection deviceeffect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars |
| Conventional syringe | Active comparator | Procedure: conventional syringeConventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6-8 years
- Cooperative children ( rating 3 or 4 based on the Frankl behavior scale )
- Medically fit children (ASA I )
- Children mentally capable of communication
- First dental visit
Key exclusion criteria (8 listed)
- Children with a behavioral management problem
- Parental refusal of participation
- Children with previous history of local anesthesia injection
- Medically unfit children (other than ASA I )
- Uncooperative children ( other than Frankl 3,4)
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 |
|---|---|---|
| Starpen automatic injection deviceAlso: computer controlled injection deviceStarpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle | Device | Starpen automatic injection device |
| conventional syringeAlso: dental syringeinjection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle | Procedure or surgery | Conventional syringe |
Primary outcome
Subjective pain during injection
Time frame: during procedure
Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.
5 secondary outcomes
Objective pain during infiltration
Time frame: during procedure
Subjective pain during extraction
Time frame: during procedure
Objective pain during extraction
Time frame: during procedure
Physiological parameters ( heart rate )
Time frame: Readings will be taken before and during anesthesia injection and during extraction.
Physiological parameter ( oxygen saturation)
Time frame: Readings will be taken before and during anesthesia injection and during extraction.
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 Sep 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Starpen automatic injection device and conventional syringe in people with Pain Perception of the New Device, run by Cairo University.
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 8 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Subjective pain during injection (time frame: during procedure). 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 Sep 2025.