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

NCT06676098 | Recruiting

• 1 other identifier: H-43160
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• Pulp vitality

  baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes

Study Arms (1)

IANBD guided Inferior Alveolar Nerve block (IANB) injection

EXPERIMENTAL

Participants will receive a guided IANB using an IANBD.

Procedure: IANBD 3D guided approach

Interventions

IANBD 3D guided approach PROCEDURE

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

IANBD guided Inferior Alveolar Nerve block (IANB) injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

Study Officials

• Tum-Yi Hsu, DMD DScD

  BU Goldman School of Dental Medicine, Endodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tum-Yi Hsu, DMD DScD

CONTACT

(617) 358-3481; thsu@bu.edu

Emily Wen, DDS

CONTACT

emilywen@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: December 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)