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Clinical Success of 12 mm Needle IANB in Children

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07791082
Enrollment
43
Registered
2026-08-27
Start date
2026-08-27
Completion date
2026-09-02
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inferior Alveolar Nerve Block in Children

Brief 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. 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

Interventions

DEVICE12 mm 30-Gauge Extra-Short Dental Needle

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.

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* • 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

Exclusion criteria

* • 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success of Inferior Alveolar Nerve BlockDuring and immediately after the dental procedureClinical 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

Secondary

MeasureTime frameDescription
Injection-Related Adverse Events and ComplicationsDuring the injection, dental procedure, and immediately after the procedureThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026