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

NCT ID: NCT06676098

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Inferior Alveolar Nerve Block

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IANBD guided Inferior Alveolar Nerve block (IANB) injection

Participants will receive a guided IANB using an IANBD.

Group Type: EXPERIMENTAL

IANBD 3D guided approach

Intervention Type: PROCEDURE

The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula

Interventions

IANBD 3D guided approach

The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tum-Yi Hsu, DMD DScD

Role: PRINCIPAL_INVESTIGATOR

BU Goldman School of Dental Medicine, Endodontics

Locations

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tum-Yi Hsu, DMD DScD

Role: CONTACT

thsu@bu.edu

(617) 358-3481

Emily Wen, DDS

Role: CONTACT

emilywen@bu.edu

Other Identifiers

H-43160

Identifier Type: -

Identifier Source: org_study_id