Pain AssessmentStarpen CCLADNCT06827223
Effect of Starpen CCLAD in Injection and Extraction
A study testing Traditional Syringe in people with Pain Assessment, run by Cairo University.
Trial summary
The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Assessment
- What is being tested?
- Traditional Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Mar 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
- Healthy volunteers accepted
- 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 are mentally capable of communication.
- First dental visit.
- Patient requiring extraction of lower primary molars due to root caries, crown fractures, periapical disease, and failed pulpotomies.
Who cannot join
- Children with a behavioral management problem.
- Parental refusal of participation.
- Children with a 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 of the root
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation of the Effect of Computer-controlled Starpen Automatic Injection Device Versus Traditional Syringe on Pain Perception During Nerve Block Anesthesia and Extraction of Mandibular Primary Molars: a Randomized Controlled Trial
The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.
Read the detailed description
Pain is "An unpleasant sensory and emotional experience connected to actual or potential tissue damage or described in terms of such damage". According to the American Academy of Pediatric Dentistry, a patient may experience serious physical and psychological complications from improper pain management.
Anxiety, a fear of dental procedures, is often linked to unpleasant stimuli such as needle phobia, high vibration, noises, pain, and the smell of materials or medications. Patients who experience anxiety often exhibit complex behavior before or during dental procedures, causing additional discomfort.
In most dental procedures, Local anesthetic (LA) is crucial to alleviate pain during dental procedures enabling the dentist to complete the process. Even though LA is used to reduce pain during the procedure, but traditional methods itself can cause pain, making pediatric patients anxious and uncooperative in dental offices.
Effective pain management is crucial for children receiving dental injections to promote comfort, cooperation, and compliance. These techniques include topical analgesics, distraction, injection rates, buffering and warming the local anesthesia, speed reduction, fine needles, and precooling. Yet, no conclusive painless injection technique has been developed yet.
Finally, The Wand system, developed in 1997 by Milestone Scientific Inc., it was the first Computer-Controlled Local Anesthesia Delivery (CCLAD)discovered. Other devices like Morpheus, Calaject, Quicksleeper, and Smartject have entered the market, these systems varying in injection speed, design, weight, and shape, so, dentists can select the one that best meets their requirements.
This device's main concept is that a local anesthetic injection is done by lowering the pressure and flow rate.
The CCLAD reduced destructive behaviors in young children who were difficult to cooperate compared to the traditional method and created a positive experience for both the patient and physician.
The main advantage of these CCLADS devices is The ability to provide a small quantity of the local anesthetic solution with a stable injection mode, which decreases the discomfort associated with less controlled injections. In both adult and pediatric dentistry, the CCLADS devices have proven effective for extractions, pulpal therapies, and restorations. Patients also tolerate them well and behave less disruptively.
The Traditional injection syringe compared with computer-controlled local analgesic delivery devices (CCLAD) regarding disruptive behavior, pain, anxiety, and biochemical parameters. The results showed lower VAS, WBS, and salivary cortisol values in CCLADS patients compared to the traditional syringe group. They concluded that a positive impact of CCLADS on pain and anxiety can be recommended for pediatric patients.
Using CCLADs is significantly less painful than using traditional syringes and opens new, promising opportunities for working with patients presenting high dental fear.
The Starpen is one of the most recent advances that is promoted as a more comfortable and painless alternative to the traditional local anesthetic syringe. It includes a power adapter, cartridge holder, handpiece, and charging base. In dental uses, it can be injected intramuscularly or subcutaneously. It comes in three different speeds-high, low, and hybrid-and two aspiration modes-manual and auto. It may be used with the majority of the conventional gauge needles.
- Conditions
- Pain Assessment
- Being tested
- computer-controlled Starpen Automatic Injection Device, Traditional Syringe
- Keywords
- Starpen CCLADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-controlled Starpen Automatic Injection DeviceDevice
using computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars
Traditional SyringeDevice
nerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | nerve block anesthesia and extraction of mandibular primary molars using a Traditional Syringe Receives: Device: Traditional Syringe |
| intervention group | Experimental | nerve block anesthesia and extraction of mandibular primary molars using Computer-controlled Starpen Automatic Injection Device Receives: Device: computer-controlled Starpen Automatic Injection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain perception during injection of local anesthesia
After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"
Measured: immediately after the procedure(injection)
Secondary outcomes (5)
objective pain perception during local anesthesia injection
During injection, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"
Measured: During the procedure (injection)
Subjective pain perception during the extraction
After extraction, the subjective pain perception will be recorded from the child by asking him to choose a face from the Wong-Baker faces pain rating scale to express his pain experience during the extraction after explaining the scale to him with scores from (0 to 10). The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable .
"the higher score means a worse outcome"
Measured: immediately after the procedure(extraction)
objective pain perception during extraction
During extraction, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"
Measured: During the procedure (extraction)
Physiological parameter (heart rate)
Physiological parameter (heart rate) with measuring unit(Beats per minute ) will be recorded at three-time points: baseline (10 minutes before the procedure), during injection, and extraction with a Pulse oximeter on the child's index finger
Measured: at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Physiological parameter (oxygen saturation)
Physiological parameter (oxygen saturation) with measuring unit(percent (%)) will be recorded at three-time points: baseline (10 minutes before the procedure), during injection, and extraction with a Pulse oximeter on the child's index finger
Measured: at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain AssessmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mostafa Abohashim Masoud Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827223
- Sponsor's protocol ID
- Starpen CCLAD in injection
- Acronym
- Starpen CCLAD
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saoji H, Nainan MT, Nanjappa N, Khairnar MR, Hishikar M, Jadhav V. Assessment of computer-controlled local anesthetic delivery system for pain control during restorative procedures: A randomized controlled trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):298-304. doi: 10.15171/joddd.2019.045.
PubMed 32190214Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.
PubMed 30143396Attia S, Austermann T, May A, Mekhemar M, Conrad J, Knitschke M, Bottger S, Howaldt HP, Riad A. Pain perception following computer-controlled versus conventional dental anesthesia: randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):425. doi: 10.1186/s12903-022-02454-1.
PubMed 36138388Janik K, Niemczyk W, Peterek R, Roj R, Balicz A, Morawiec T. Computer-Controlled Local Anaesthesia Delivery efficacy - a literature review. Saudi Dent J. 2024 Aug;36(8):1066-1071. doi: 10.1016/j.sdentj.2024.05.012. Epub 2024 May 31.
PubMed 39176166Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
PubMed 26156269Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.
PubMed 38239164
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effect of Computer-controlled Starpen Automatic Injection Device Versus Traditional Syringe on Pain Perception During Nerve Block Anesthesia and Extraction of Mandibular Primary Molars: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06827223
- Acronym / sponsor ID
- Starpen CCLAD / Starpen CCLAD in injection
- Conditions
- Pain Assessment
- Keywords
- Starpen CCLADS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Feb 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 present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.
Detailed description
Pain is "An unpleasant sensory and emotional experience connected to actual or potential tissue damage or described in terms of such damage". According to the American Academy of Pediatric Dentistry, a patient may experience serious physical and psychological complications from improper pain management.
Anxiety, a fear of dental procedures, is often linked to unpleasant stimuli such as needle phobia, high vibration, noises, pain, and the smell of materials or medications. Patients who experience anxiety often exhibit complex behavior before or during dental procedures, causing additional discomfort.
In most dental procedures, Local anesthetic (LA) is crucial to alleviate pain during dental procedures enabling the dentist to complete the process. Even though LA is used to reduce pain during the procedure, but traditional methods itself can cause pain, making pediatric patients anxious and uncooperative in dental offices.
Effective pain management is crucial for children receiving dental injections to promote comfort, cooperation, and compliance. These techniques include topical analgesics, distraction, injection rates, buffering and warming the local anesthesia, speed reduction, fine needles, and precooling. Yet, no conclusive painless injection technique has been developed yet.
Finally, The Wand system, developed in 1997 by Milestone Scientific Inc., it was the first Computer-Controlled Local Anesthesia Delivery (CCLAD)discovered. Other devices like Morpheus, Calaject, Quicksleeper, and Smartject have entered the market, these systems varying in injection speed, design, weight, and shape, so, dentists can select the one that best meets their requirements.
This device's main concept is that a local anesthetic injection is done by lowering the pressure and flow rate.
The CCLAD reduced destructive behaviors in young children who were difficult to cooperate compared to the traditional method and created a positive experience for both the patient and physician.
The main advantage of these CCLADS devices is The ability to provide a small quantity of the local anesthetic solution with a stable injection mode, which decreases the discomfort associated with less controlled injections. In both adult and pediatric dentistry, the CCLADS devices have proven effective for extractions, pulpal therapies, and restorations. Patients also tolerate them well and behave less disruptively.
The Traditional injection syringe compared with computer-controlled local analgesic delivery devices (CCLAD) regarding disruptive behavior, pain, anxiety, and biochemical parameters. The results showed lower VAS, WBS, and salivary cortisol values in CCLADS patients compared to the traditional syringe group. They concluded that a positive impact of CCLADS on pain and anxiety can be recommended for pediatric patients.
Using CCLADs is significantly less painful than using traditional syringes and opens new, promising opportunities for working with patients presenting high dental fear.
The Starpen is one of the most recent advances that is promoted as a more comfortable and painless alternative to the traditional local anesthetic syringe. It includes a power adapter, cartridge holder, handpiece, and charging base. In dental uses, it can be injected intramuscularly or subcutaneously. It comes in three different speeds-high, low, and hybrid-and two aspiration modes-manual and auto. It may be used with the majority of the conventional gauge needles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: Traditional Syringenerve block anesthesia and extraction of mandibular primary molars using a Traditional Syringe |
| intervention group | Experimental | Device: computer-controlled Starpen Automatic Injection Devicenerve block anesthesia and extraction of mandibular primary molars using Computer-controlled Starpen Automatic Injection Device |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-8 years
- Cooperative children (Rating 3 or 4 based on the Frankl behavior scale)
- Medically fit children (ASA I).
- Children are mentally capable of communication.
- First dental visit.
Key exclusion criteria (7 listed)
- Children with a behavioral management problem.
- Parental refusal of participation.
- Children with a 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 |
|---|---|---|
| computer-controlled Starpen Automatic Injection Deviceusing computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars | Device | intervention group |
| Traditional Syringenerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe | Device | control group |
Primary outcome
Subjective Pain perception during injection of local anesthesia
Time frame: immediately after the procedure(injection)
After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"
5 secondary outcomes
objective pain perception during local anesthesia injection
Time frame: During the procedure (injection)
Subjective pain perception during the extraction
Time frame: immediately after the procedure(extraction)
objective pain perception during extraction
Time frame: During the procedure (extraction)
Physiological parameter (heart rate)
Time frame: at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Physiological parameter (oxygen saturation)
Time frame: at baseline(10 minutes before the procedure) and during both procedures (injection and 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 14 Feb 2025.
- Background: PubMed 32190214Saoji H, Nainan MT, Nanjappa N, Khairnar MR, Hishikar M, Jadhav V. Assessment of computer-controlled local anesthetic delivery system for pain control during restorative procedures: A randomized controlled trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):298-304. doi: 10.15171/joddd.2019.045.
- Background: PubMed 30143396Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.
- Background: PubMed 36138388Attia S, Austermann T, May A, Mekhemar M, Conrad J, Knitschke M, Bottger S, Howaldt HP, Riad A. Pain perception following computer-controlled versus conventional dental anesthesia: randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):425. doi: 10.1186/s12903-022-02454-1.
- Background: PubMed 39176166Janik K, Niemczyk W, Peterek R, Roj R, Balicz A, Morawiec T. Computer-Controlled Local Anaesthesia Delivery efficacy - a literature review. Saudi Dent J. 2024 Aug;36(8):1066-1071. doi: 10.1016/j.sdentj.2024.05.012. Epub 2024 May 31.
- Background: PubMed 26156269Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
- Background: PubMed 38239164Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Syringe in people with Pain Assessment, 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 6 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: opening soon, as of the sponsor's last update on 14 Feb 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?
Contact Sara M Soliman, Bachelor's degree 2020 (00201009740402, sara.masoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Pain perception during injection of local anesthesia (time frame: immediately after the procedure(injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827223, which also lists 6 linked publications.
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 Feb 2025.