Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06676098 | RECRUITING | Inferior Alveolar Nerve Block

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

Condition or disease

Inferior Alveolar Nerve Block

Intervention/treatment

IANBD 3D guided approach

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
Actual Study Start Date : 2026-01
Estimated Primary Completion Date : 2027-11
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)

Location Details

NCT06676098

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, United States, 02118