Goldman School of Dental Medicine, Boston University
Boston, Massachusetts, 02118, United States
Location status: Recruiting
NCT Number: NCT06676098
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Emily Wen, DDS
CONTACT
Tum-Yi Hsu, DMD DScD
CONTACT
Boston University
Other
The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
Acronym: IANBD
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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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