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NCT Number: NCT06676098

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IANBD 3D guided approach

Procedure

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

Primary outcomes

  1. Participant acceptability

    Time frame: 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.

  2. Clinician acceptability

    Time frame: 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.

  3. Safety of IANBD based on number of adverse events

    Time frame: 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.

  4. Safety of IANBD based on type of adverse events

    Time frame: 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.

Secondary outcomes

  1. Pulp vitality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Wen, DDS

CONTACT

[email protected]

Tum-Yi Hsu, DMD DScD

CONTACT

[email protected]

(617) 358-3481

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial

Acronym: IANBD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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