Pain PerceptionNCT06129162
Pain Perception Comparison of Computerized vs Conventional Injection Methods
A study testing Conventional Syringe, STA Single Tooth Anesthesia® System. and Star Pen anesthesia device. in people with Pain Perception and Local Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception, Local Anesthesia
- What is being tested?
- Conventional Syringe, STA Single Tooth Anesthesia® System. and Star Pen anesthesia device.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Jun 2024
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children (5-8) years old, and free from systemic diseases.
- Children who require local anesthetic injection for any dental treatment.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children who have no contraindications to the usage of selected local anesthetic agents.
Who cannot join
- All that does not correspond to inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry
Al Mansurah, Dakahlia Governorate, 35511
Osamah M Almekhlafi, Master, 00201141630514, dr.osamah.sp@hotmail.com
About this study
Official title: A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems
This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.
Read the detailed description
The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.
- Conditions
- Pain Perception, Local Anesthesia
- Being tested
- Conventional Syringe, STA Single Tooth Anesthesia® System., Star Pen anesthesia device.
- Keywords
- Pain perception, Inferior Alveolar Nerve, Infiltration, Local Anesthesia, STA Single Tooth Anesthesia® System, Star Pen anesthesia device, Conventional syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SyringeDevice
Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.
STA Single Tooth Anesthesia® System.Device
Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.
Star Pen anesthesia device.Device
Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Control Group | Active comparator | Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique. Receives: Device: STA Single Tooth Anesthesia® System.; Device: Star Pen anesthesia device. |
| Group II: STA group | Experimental | Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique. Receives: Device: Conventional Syringe; Device: Star Pen anesthesia device. |
| Group III: Star pen group | Experimental | Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique. Receives: Device: Conventional Syringe; Device: STA Single Tooth Anesthesia® System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of pain perception by Wong-Baker FACES Pain Rating scale
The primary outcome was evaluated using Wong-Baker FACES Pain Rating scale. The child was briefly explained about each face and then asked to select the face that best described their feelings during the administration of local anesthesia. The scale consists of 6 cartoon faces depicting varying facial expressions, ranging from a very happy face (score 0) to a very sad one (score 10).
Measured: Up to 12 weeks.
scale of pain perception by Sounds, eyes, and motor (SEM) scale.
The primary outcome was evaluated using Sounds, eyes, and motor (SEM) scale. These responses are categorized on a scale ranging from 1-4 categories comfort, mild discomfort, moderately painful, and painful. Two pediatric dentists who are blind to injection devises will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two.
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Oct 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PerceptionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Selected children will be divided randomly into 3 groups: * Control group (Group I). * STA group (Group II). * Star pen group (Group III).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osamah Mohammed Abdulghani Almekhlafi, Mansoura University
- Investigators
- Osamah M Almekhlafi, Master, Principal investigator, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura UniversitySalwa M Awad, Prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura UniversityRizk A Elagamy, PhD, Study director, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129162
- Sponsor's protocol ID
- A0108023PP
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems
- ClinicalTrials.gov ID
- NCT06129162
- Acronym / sponsor ID
- A0108023PP
- Conditions
- Pain Perception, Local Anesthesia
- Keywords
- Pain perception, Inferior Alveolar Nerve, Infiltration, Local Anesthesia, STA Single Tooth Anesthesia® System, Star Pen anesthesia device, Conventional syringe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (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 study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.
Detailed description
The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Selected children will be divided randomly into 3 groups: * Control group (Group I). * STA group (Group II). * Star pen group (Group III).
| Arm | Type | Receives |
|---|---|---|
| Group I: Control Group | Active comparator | Device: STA Single Tooth Anesthesia® System., Device: Star Pen anesthesia device.Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique. |
| Group II: STA group | Experimental | Device: Conventional Syringe, Device: Star Pen anesthesia device.Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique. |
| Group III: Star pen group | Experimental | Device: Conventional Syringe, Device: STA Single Tooth Anesthesia® System.Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Apparently healthy children (5-8) years old, and free from systemic diseases.
- Children who require local anesthetic injection for any dental treatment.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children who have no contraindications to the usage of selected local anesthetic agents.
Key exclusion criteria (1 listed)
- All that does not correspond to inclusion criteria.
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 |
|---|---|---|
| Conventional SyringeDental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration. | Device | Group II: STA group, Group III: Star pen group |
| STA Single Tooth Anesthesia® System.Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration. | Device | Group I: Control Group, Group III: Star pen group |
| Star Pen anesthesia device.Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration. | Device | Group I: Control Group, Group II: STA group |
Primary outcome
scale of pain perception by Wong-Baker FACES Pain Rating scale
Time frame: Up to 12 weeks.
The primary outcome was evaluated using Wong-Baker FACES Pain Rating scale. The child was briefly explained about each face and then asked to select the face that best described their feelings during the administration of local anesthesia. The scale consists of 6 cartoon faces depicting varying facial expressions, ranging from a very happy face (score 0) to a very sad one (score 10).
scale of pain perception by Sounds, eyes, and motor (SEM) scale.
Time frame: Up to 12 weeks.
The primary outcome was evaluated using Sounds, eyes, and motor (SEM) scale. These responses are categorized on a scale ranging from 1-4 categories comfort, mild discomfort, moderately painful, and painful. Two pediatric dentists who are blind to injection devises will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Yes. Study Protocol to other researchers
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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.
Osamah M Almekhlafi, Master principal investigator
Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
Salwa M Awad, Prof study director
Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
Rizk A Elagamy, PhD study director
Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
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 Syringe, STA Single Tooth Anesthesia® System. and Star Pen anesthesia device. in people with Pain Perception and Local Anesthesia, run by Mansoura University 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 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osamah M Almekhlafi, Master (00201141630514, dr.osamah.sp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scale of pain perception by Wong-Baker FACES Pain Rating scale (time frame: Up to 12 weeks.). 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 13 Nov 2023.