Pain PerceptionNCT07575035
EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS
A study testing Experimental Group (CC-ILA using Super Pen) in people with Pain Perception, run by Shatha Musaad Alharthi at 1 site in Egypt.
Trial summary
The aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB). Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Pain Perception
- What is being tested?
- Experimental Group (CC-ILA using Super Pen)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Aug 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-7 years.
- Children free from systemic diseases or special healthcare needs (ASAI).14
- No previous negative dental experiences.15
- Positive or definitely positive preoperative behaviour, according to the Frankl Behaviour Rating Scale (scores 3 or 4) (Appendix I).16
- Mandibular primary molars indicated for extraction.17,18
- Parental consent to participate in the study.
Who cannot join
- Root resorption exceeding one-third of root length or signs of mobility.
- Fractured roots
- Ankylosed roots.
- Active infection or pathosis at the injection site.
- History of allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Shatha AlHarthi, BDS, +966 54 107 7444, shatha.al-harthi@hotmail.com
About this study
Official title: EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS (RANDOMIZED CONTROLLED CLINICAL TRIAL)
The aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB).
- Conditions
- Pain Perception
- Being tested
- Experimental Group (CC-ILA using Super Pen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group (CC-ILA using Super Pen)Device
- A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone.
- Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.
- The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.
| Study group | Role | What they receive |
|---|---|---|
| A) Experimental Group (CC-ILA using Super Pen) | Experimental | A) Experimental Group (CC-ILA using Super Pen)
* CC-ILA will be administered with the Super Pen according to manufacturer instructions.
* A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone.
* Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.24
* The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle. Receives: Device: Experimental Group (CC-ILA using Super Pen) |
| B) Control Group (Conventional IANB Technique) | Active comparator | * A 27-gauge 3 cm long needle will be used to administer Articaine 4% with 1:100,000 epinephrine via the standard IANB approach, followed by long buccal infiltration.
* After negative aspiration, approximately 1.0 mL of solution will be delivered near the inferior alveolar nerve, and 0.5 mL as a buccal infiltration distal to the second primary molar.25
* Anesthesia onset will be confirmed by gingival probing at 10-second intervals (CC-ILA) or 30-second intervals (IANB). Receives: Device: Experimental Group (CC-ILA using Super Pen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.
Measured: immediately after the procedure (within the same treatment visit)
Oxygen saturation
Oxygen saturation will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.
Measured: immediately after the procedure (within the same treatment visit)
Secondary outcomes (2)
Objective Pain assessment
Pain will be assessed using the Sound, Eye, and Motor (SEM) Scale. Each component will be graded from 1 (comfort) to 4 (severe discomfort) by the operator and the independent outcome assessor evaluator reviewing video recordings.
Measured: immediately after the procedure (within the same treatment visit).
Subjective Pain assessment
Pain perception will be recorded after anesthesia and Extraction using a modified facial expression scale. Children will choose from three schematic faces representing satisfaction, indifference, or dissatisfaction.
Measured: immediately after the procedure (within the same treatment visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shatha Musaad Alharthi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shatha Musaad Alharthi, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575035
- Sponsor's protocol ID
- 1208-12/2025
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS (RANDOMIZED CONTROLLED CLINICAL TRIAL)
- ClinicalTrials.gov ID
- NCT07575035
- Acronym / sponsor ID
- 1208-12/2025
- Conditions
- Pain Perception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shatha Musaad AlharthiUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 May 2026 (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 aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A) Experimental Group (CC-ILA using Super Pen) | Experimental | Device: Experimental Group (CC-ILA using Super Pen)A) Experimental Group (CC-ILA using Super Pen) * CC-ILA will be administered with the Super Pen according to manufacturer instructions. * A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. * Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root.24 * The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle. |
| B) Control Group (Conventional IANB Technique) | Active comparator | Device: Experimental Group (CC-ILA using Super Pen)* A 27-gauge 3 cm long needle will be used to administer Articaine 4% with 1:100,000 epinephrine via the standard IANB approach, followed by long buccal infiltration. * After negative aspiration, approximately 1.0 mL of solution will be delivered near the inferior alveolar nerve, and 0.5 mL as a buccal infiltration distal to the second primary molar.25 * Anesthesia onset will be confirmed by gingival probing at 10-second intervals (CC-ILA) or 30-second intervals (IANB). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 5-7 years.
- Children free from systemic diseases or special healthcare needs (ASAI).14
- No previous negative dental experiences.15
- Positive or definitely positive preoperative behaviour, according to the Frankl Behaviour Rating Scale (scores 3 or 4) (Appendix I).16
- Mandibular primary molars indicated for extraction.17,18
Key exclusion criteria (5 listed)
- Root resorption exceeding one-third of root length or signs of mobility.
- Fractured roots
- Ankylosed roots.
- Active infection or pathosis at the injection site.
- History of allergy to 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 |
|---|---|---|
| Experimental Group (CC-ILA using Super Pen)* A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. * Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root. * The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle. | Device | A) Experimental Group (CC-ILA using Super Pen), B) Control Group (Conventional IANB Technique) |
Primary outcome
Heart rate
Time frame: immediately after the procedure (within the same treatment visit)
Heart rate will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.
Oxygen saturation
Time frame: immediately after the procedure (within the same treatment visit)
Oxygen saturation will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.
2 secondary outcomes
Objective Pain assessment
Time frame: immediately after the procedure (within the same treatment visit).
Subjective Pain assessment
Time frame: immediately after the procedure (within the same treatment visit).
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 8 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (CC-ILA using Super Pen) in people with Pain Perception, run by Shatha Musaad Alharthi 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 6 inclusion and 5 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 8 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 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?
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 Shatha M Alharthi, BDS (+966541077444, shatha.al-harthi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: immediately after the procedure (within the same treatment visit)). 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 8 May 2026.