Clinical Success of 12 mm Needle IANB in Children

NCT07791082 | Not Yet Recruiting

• 1 other identifier: AUAREC20260007-3
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Conditions

Clinical Success and Safety of Inferior Alveolar Nerve Block Using a 12 mm 30-gauge Extra-short Needle in Children

Outcome Measures

Primary Outcomes (1)

• Clinical Success of Inferior Alveolar Nerve Block

  child reports no pain or mild pain during treatment on a simple facial pain scale, and no supplementary anesthesia is required.

  During and immediately after the dental procedure

Secondary Outcomes (1)

• Injection-Related Adverse Events and Complications

  During the injection, dental procedure, and immediately after the procedure

Study Arms (1)

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

Device: 12 mm 30-Gauge Extra-Short Dental Needle

Interventions

12 mm 30-Gauge Extra-Short Dental Needle DEVICE

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.

Inferior Alveolar Nerve Block Using a 12 mm Needle

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08