Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06676098

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

Led by Boston University · Updated on 2026-01-27

10

Participants Needed

1

Research Sites

97 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient of Henry M. Goldman School of Dentistry
  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

T

Tum-Yi Hsu, DMD DScD

CONTACT

E

Emily Wen, DDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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