Best injection spot for a 3D-guided inferior alveolar nerve block device
The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
This trial tests whether a CBCT-based 3D-guided device can place inferior alveolar nerve block injections more accurately for patients needing root canal treatment on lower molars or premolars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06676098 on ClinicalTrials.gov |
What this trial studies
Mandibular teeth often require an inferior alveolar nerve block (IANB), but traditional landmark-based IANB is a blind technique with reported failure rates up to 30–45%. This interventional protocol uses a cone beam CT (CBCT)-guided, patient-specific 3D device (IANBD) to direct the needle toward the mandibular foramen. Eligible patients will receive a clinically indicated CBCT and a guided IANB using the 3D device, with outcomes focused on first-attempt anesthesia success, tissue impact, and patient discomfort. The work is conducted at Boston University's Goldman School of Dental Medicine.
Who should consider this trial
Good fit: Adults treated at Boston University's Goldman School of Dental Medicine who are ASA I, need non-surgical endodontic therapy on a mandibular molar or premolar, have an asymptomatic pulpal diagnosis, a quadrant with at least three vital teeth, will receive a clinically indicated CBCT, and agree to guided IANB are ideal candidates.
Not a fit: Patients who are pregnant, allergic to lidocaine, articaine, or resin, have prior jaw surgery, have teeth unresponsive to thermal testing, or cannot/decline to have a CBCT or guided injection are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, patients could achieve reliable anesthesia on the first injection with fewer needle passes, less tissue trauma, and reduced injection-related discomfort.
How similar studies have performed: Image-guided mandibular anesthesia approaches using CBCT and navigation have shown improved needle placement accuracy in prior reports, but this specific 3D-guided IANBD device is a relatively novel investigational application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Goldman School of Dental Medicine, Boston University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Tum-Yi Hsu, DMD DScD — BU Goldman School of Dental Medicine, Endodontics
- Study coordinator: Tum-Yi Hsu, DMD DScD
- Email: thsu@bu.edu
- Phone: (617) 358-3481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.