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The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)

Study acronym: IANBD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of Jan 2026 to Dec 17, 2025v11
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2025 to Jan 2026
    • Study sites: 0 to 1
    v10
  3. Notable Primary and study completion dates: Nov 2026 to Nov 2027
    • Start date: Oct 2025 to Nov 2025
    v9
  4. Notable Start date: Aug 2025 to Oct 2025v8
  5. Minor Start date: Jul 2025 to Aug 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv6
  2. Minor Start date: Jun 2025 to Jul 2025v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Start date: Mar 2025 to Jun 2025v3
  5. Minor Start date: Jan 2025 to Mar 2025v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Given the thicker cortical bone in the mandible compared to the maxilla, mandibular teeth cannot be effectively anesthetized via local infiltration anesthesia. Instead, clinicians typically perform regional anesthesia and most commonly, Inferior Alveolar Nerve block (IANB). However, the inferior alveolar nerve is deeply submerged by surrounding structures of bone, muscles, ligaments and vessels. Traditional IANB is a technique by using anatomical landmarks not directly related to Inferior Alveolar Nerve (IAN) to approximate the location of mandibular foramen, where IAN enters mandible. IANB is considered a blind technique and known for the lack of accuracy and precision. The failure rate can be as high as 30-45%. In contrast, the investigator's cone beam computed tomography (CBCT) guided IANB device (IANBD) effectively directs the needle to the mandibular foramen which improves the success rate of the IANB on the first attempt, minimizes injection tissue damage, and reduces patient discomfort. In this proof of concept trial, a 3D printed CBCT guided IANBD will be used to administer anesthesia at three injection sites instead of the traditional IANB technique. Participants will be consented patients at the postdoctoral endodontic treatment center, Department of Endodontics, Boston University (BU) Henry M. Goldman School of Dentistry. The goal of this research is to to evaluate the acceptability, safety, and effectiveness of guided anesthesia using the IANBD by enrolling 10 subjects who require non-surgical endodontic therapy with a simple, affordable and reliable prototype to be used by clinicians in the dental care setting.
Trial Details
NCT Number NCT06676098
Lead Sponsor Boston University
Conditions
(from sponsor)
Inferior Alveolar Nerve Block
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov