Inferior Alveolar Nerve Block in ChildrenNCT07791082
Clinical Success of 12 mm Needle IANB in Children
A study testing 12 mm 30-Gauge Extra-Short Dental Needle in people with Inferior Alveolar Nerve Block in Children, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This prospective single-arm pilot study will evaluate the clinical success of an inferior alveolar nerve block performed using a 12 mm 30-gauge extra-short dental needle in children aged 4 to 12 years. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Block in Children
- What is being tested?
- 12 mm 30-Gauge Extra-Short Dental Needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2026to 2 Sep 2026
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Age 4-12 years
- Mandibular primary or permanent tooth requiring extraction or pulp therapy
- Frankl behavior not definitely negative
- Able to provide age-appropriate self-report on a facial pain scale
Who cannot join
- • Definitely negative Frankl behavior
- Need for sedation or general anesthesia
- Communication or neurologic limitations preventing reliable pain scoring
- Allergy/contraindication to local anesthetic
- Acute infection at injection site or other contraindication to routine IANB
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Al-Azhar University
Asyut
About this study
Official title: Prospective Single-Arm Pilot Study of Clinical Success and Safety of Inferior Alveolar Nerve Block Using a 12 mm 30-Gauge Extra-Short Needle in Children Aged 4-12 Years
This prospective single-arm pilot study will evaluate the clinical success of an inferior alveolar nerve block performed using a 12 mm 30-gauge extra-short dental needle in children aged 4 to 12 years. The study will assess whether this needle length can provide effective local anesthesia for dental treatment in children while minimizing potential complications associated with greater needle penetration. The study will also document any adverse events or complications related to the injection technique
- Being tested
- 12 mm 30-Gauge Extra-Short Dental Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mm 30-Gauge Extra-Short Dental NeedleDevice
A 12 mm, 30-gauge extra-short dental needle will be used to administer an inferior alveolar nerve block for local anesthesia during dental treatment in children aged 4 to 12 years. The clinical success of the nerve block and any injection-related adverse events or complications will be assessed and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar Nerve Block Using a 12 mm Needle | Experimental | Children will receive an inferior alveolar nerve block using a 12 mm, 30-gauge extra-short dental needle for local anesthesia during dental treatment. Clinical success and any adverse events or complications related to the injection will be recorded Receives: Device: 12 mm 30-Gauge Extra-Short Dental Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Inferior Alveolar Nerve Block
Clinical success will be defined as a pain score of 0 (no pain) or 1 (mild pain) during dental treatment, with no requirement for supplementary anesthesia, using the [Simple-facial pain scale] (0 = no pain; 3 = severe pain). Higher scores indicate greater pain and therefore a worse outcome
Measured: During and immediately after the dental procedure
Secondary outcomes (1)
Injection-Related Adverse Events and Complications
The occurrence and type of adverse events or complications related to administration of the inferior alveolar nerve block will be recorded, including pain during needle insertion and any other clinically relevant injection-related complications
Measured: During the injection, dental procedure, and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start27 Aug 2026
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Alveolar Nerve Block in ChildrenStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taha Elfezary, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791082
- Sponsor's protocol ID
- AUAREC20260007-3
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Arm Pilot Study of Clinical Success and Safety of Inferior Alveolar Nerve Block Using a 12 mm 30-Gauge Extra-Short Needle in Children Aged 4-12 Years
- ClinicalTrials.gov ID
- NCT07791082
- Acronym / sponsor ID
- AUAREC20260007-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 27 Aug 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.
This prospective single-arm pilot study will evaluate the clinical success of an inferior alveolar nerve block performed using a 12 mm 30-gauge extra-short dental needle in children aged 4 to 12 years. The study will assess whether this needle length can provide effective local anesthesia for dental treatment in children while minimizing potential complications associated with greater needle penetration. The study will also document any adverse events or complications related to the injection technique
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveolar Nerve Block Using a 12 mm Needle | Experimental | Device: 12 mm 30-Gauge Extra-Short Dental NeedleChildren will receive an inferior alveolar nerve block using a 12 mm, 30-gauge extra-short dental needle for local anesthesia during dental treatment. Clinical success and any adverse events or complications related to the injection will be recorded |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Age 4-12 years
Key exclusion criteria (5 listed)
- • Definitely negative Frankl behavior
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 |
|---|---|---|
| 12 mm 30-Gauge Extra-Short Dental NeedleA 12 mm, 30-gauge extra-short dental needle will be used to administer an inferior alveolar nerve block for local anesthesia during dental treatment in children aged 4 to 12 years. The clinical success of the nerve block and any injection-related adverse events or complications will be assessed and recorded. | Device | Inferior Alveolar Nerve Block Using a 12 mm Needle |
Primary outcome
Clinical Success of Inferior Alveolar Nerve Block
Time frame: During and immediately after the dental procedure
Clinical success will be defined as a pain score of 0 (no pain) or 1 (mild pain) during dental treatment, with no requirement for supplementary anesthesia, using the [Simple-facial pain scale] (0 = no pain; 3 = severe pain). Higher scores indicate greater pain and therefore a worse outcome
1 secondary outcome
Injection-Related Adverse Events and Complications
Time frame: During the injection, dental procedure, and immediately after the 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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 12 mm 30-Gauge Extra-Short Dental Needle in people with Inferior Alveolar Nerve Block in Children, run by Al-Azhar 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 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: finished, as of the sponsor's last update on 4 Sep 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?
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?
Clinical Success of Inferior Alveolar Nerve Block (time frame: During and immediately after the dental 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 2026.