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

Not Applicable

Not yet recruiting

• Conditions: Inferior Alveolar Nerve Block

• Registration Number: NCT06676098
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-04
• Study Start: 2025-07
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participant acceptability	30 minutes post dental procedure	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.
Safety of IANBD based on number of adverse events	at the end of the study, about 2 years	The number of adverse events that occur will be abstracted from records of the procedure for each participant.
Safety of IANBD based on type of adverse events	at the end of the study, about 2 years	The types of adverse events that occur will be abstracted from records of the procedure for each participant.
Clinician acceptability	30 minutes post dental procedure	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.

Secondary Outcome Measures

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