Recruiting

IANB Device

Sponsor:

Boston University

Code:

NCT06676098

Conditions

Inferior Alveolar Nerve Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IANBD 3D guided approach

Study Details

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 ID

NCT06676098

Start date

Dec 17, 2025

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IANBD guided Inferior Alveolar Nerve block (IANB) injection

Participants will receive a guided IANB using an IANBD.

Interventions

IANBD 3D guided approach

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

Primary outcome measure

  • Participant acceptability [ Time Frame: 30 minutes post dental procedure ]
  • Clinician acceptability [ Time Frame: 30 minutes post dental procedure ]
  • Safety of IANBD based on number of adverse events [ Time Frame: at the end of the study, about 2 years ]
  • Safety of IANBD based on type of adverse events [ Time Frame: at the end of the study, about 2 years ]

Central Contacts and Locations

Central contacts

Tum-Yi Hsu, DMD DScD

(617) 358-3481thsu@bu.edu

Emily Wen, DDS

emilywen@bu.edu

Locations

Goldman School of Dental Medicine, Boston University

Recruiting

Boston, Massachusetts, United States, 02118

More Information

Sponsor

Boston University

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • Inferior alveolar nerve block (IANB)
  • Inferior alveolar nerve block device (IANBD)
  • 3D guided IANBD
  • Cone beam computed tomography (CBCT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-01-27.