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

The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Inferior Alveolar Nerve Block
• Intervention / Treatment: Procedure: IANBD 3D guided approach

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tum-Yi Hsu, DMD DScD; Phone Number: (617) 358-3481; Email: thsu@bu.edu
• Study Contact Backup: Name: Emily Wen, DDS; Email: emilywen@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Goldman School of Dental Medicine, Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient of Henry M. Goldman School of Dentistry (GSDM)
• Medical History indicating American Society of Anesthesiology (ASA)1
• Need Non-surgical Endodontic Therapy on Mandibular Molar or Premolar
• Asymptomatic pulpal diagnosis (normal, necrotic, asymptomatic irreversible pulpitis, retreatment with no symptoms)
• The quadrant to be treated must have at least 3 vital teeth.
• Going to receive a CBCT required for clinical purposes
• Must be willing to receive guided IANB

Exclusion Criteria:

• Allergy to lidocaine or articaine
• Resin allergy
• Normal teeth unresponsive to thermal testing (ie calcified chamber)
• Prior jaw surgery
• Currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IANBD guided Inferior Alveolar Nerve block (IANB) injection; Participants will receive a guided IANB using an IANBD.	Procedure: IANBD 3D guided approach; The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician acceptability	For this proof of concept trial, the investigators developed a questionnaire with 5 open-ended questions asking clinicians; 1) how easy was it to set up the IANBD, 2) how time consuming was it to use the IANBD, 3) could you visualize the needle with the device, 4) are you likely to switch to the IANBD, and 5) compare this technique with previous IANB methods. The responses will be assessed to determine if overall the IANBD was acceptable or not to each clinician.	30 minutes post dental procedure
Safety of IANBD based on number of adverse events	The number of adverse events that occur will be abstracted from records of the procedure for each participant.	at the end of the study, about 2 years
Safety of IANBD based on type of adverse events	The types of adverse events that occur will be abstracted from records of the procedure for each participant.	at the end of the study, about 2 years
Participant acceptability	For this proof of concept trial, the investigators developed a questionnaire with 3 open-ended questions asking participants; 1) did they have mandibular anesthesia before for a dental procedure and if yes how did this compare, 2) was the size of the device acceptable, and 3) was the taste of the device acceptable. The responses will be assessed to determine if overall the IANBD was acceptable or not to each participant.	30 minutes post dental procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulp vitality	The Cold test will be done to assess pulpal vitality/anesthesia. If the Cold test is negative, the anesthesia is successful.	baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Tum-Yi Hsu, DMD DScD, BU Goldman School of Dental Medicine, Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cone beam computed tomography (CBCT); Inferior alveolar nerve block (IANB); Inferior alveolar nerve block device (IANBD); 3D guided IANBD
• Other Study ID Numbers: H-43160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No