Inferior Alveolar Nerve BlockIANBDNCT06676098
The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)
A study testing IANBD 3D guided approach in people with Inferior Alveolar Nerve Block, run by Boston University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Alveolar Nerve Block
- What is being tested?
- IANBD 3D guided approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to lidocaine or articaine
- Resin allergy
- Normal teeth unresponsive to thermal testing (ie calcified chamber)
- Prior jaw surgery
- Currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Wen, DDS contact
United States1 site, 1 recruiting
- Recruiting
Goldman School of Dental Medicine, Boston University
Boston, Massachusetts, 02118
About this study
Official title: The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
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.
- Conditions
- Inferior Alveolar Nerve Block
- Being tested
- IANBD 3D guided approach
- Keywords
- Inferior alveolar nerve block (IANB), Inferior alveolar nerve block device (IANBD), 3D guided IANBD, Cone beam computed tomography (CBCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IANBD 3D guided approachProcedure or surgery
The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula
| Study group | Role | What they receive |
|---|---|---|
| IANBD guided Inferior Alveolar Nerve block (IANB) injection | Experimental | Participants will receive a guided IANB using an IANBD. Receives: Procedure: IANBD 3D guided approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant acceptability
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.
Measured: 30 minutes post dental procedure
Clinician acceptability
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.
Measured: 30 minutes post dental procedure
Safety of IANBD based on number of adverse events
The number of adverse events that occur will be abstracted from records of the procedure for each participant.
Measured: at the end of the study, about 2 years
Safety of IANBD based on type of adverse events
The types of adverse events that occur will be abstracted from records of the procedure for each participant.
Measured: at the end of the study, about 2 years
Secondary outcomes (1)
Pulp vitality
The Cold test will be done to assess pulpal vitality/anesthesia. If the Cold test is negative, the anesthesia is successful.
Measured: baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start17 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Alveolar Nerve BlockStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tum-Yi Hsu, DMD DScD, Principal investigator, BU Goldman School of Dental Medicine, Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676098
- Sponsor's protocol ID
- H-43160
- Acronym
- IANBD
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06676098
- Acronym / sponsor ID
- IANBD / H-43160
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IANBD guided Inferior Alveolar Nerve block (IANB) injection | Experimental | Procedure: IANBD 3D guided approachParticipants will receive a guided IANB using an IANBD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- Allergy to lidocaine or articaine
- Resin allergy
- Normal teeth unresponsive to thermal testing (ie calcified chamber)
- Prior jaw surgery
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IANBD 3D guided approachThe IANBD will be used to administer the dental anesthetic 2mm medial to the lingula | Procedure or surgery | IANBD guided Inferior Alveolar Nerve block (IANB) injection |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Pulp vitality
Time frame: baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Anesthetic Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Wen, DDS contact
Tum-Yi Hsu, DMD DScD principal investigator
BU Goldman School of Dental Medicine, Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IANBD 3D guided approach in people with Inferior Alveolar Nerve Block, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tum-Yi Hsu, DMD DScD ((617) 358-3481, thsu@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant acceptability (time frame: 30 minutes post dental procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.