Clinical trial NCT06676098: The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)
Official title: The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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)
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Participant acceptability
timeFrame: 30 minutes post dental procedure
measure: Clinician acceptability
timeFrame: 30 minutes post dental procedure
measure: Safety of IANBD based on number of adverse events
timeFrame: at the end of the study, about 2 years
measure: Safety of IANBD based on type of adverse events
timeFrame: at the end of the study, about 2 years
Secondary outcomes:
measure: Pulp vitality
timeFrame: baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes
Other outcomes:
Locations:
Study officials:
affiliation: BU Goldman School of Dental Medicine, Endodontics
name: Tum-Yi Hsu, DMD DScD
role: PRINCIPAL_INVESTIGATOR
References: