10 Participants Needed

3D Guided IANB for Inferior Alveolar Nerve Block

(IANBD Trial)

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EW
Overseen ByEmily Wen, DDS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for administering anesthesia for dental work on the lower jaw using a special 3D-guided device (IANBD 3D guided approach). The goal is to increase accuracy, reduce pain, and improve first-attempt success compared to the traditional method. It is ideal for patients needing non-surgical root canal therapy on their lower molars or premolars at Boston University's dental school. Participants should have a history indicating they can safely undergo anesthesia and must be willing to try this new guided method. As an unphased trial, this study offers patients a unique opportunity to experience cutting-edge dental technology and contribute to advancements in dental care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3D guided IANB device is safe for use in dental procedures?

Studies have shown that the traditional Inferior Alveolar Nerve Block (IANB) works 60-80% of the time, but the needle placement is often incorrect. The 3D guided approach using the IANBD aims to improve accuracy in needle placement. Research indicates that this new method can increase the likelihood of correct placement on the first try, resulting in less tissue damage and discomfort for patients.

Regarding safety, one study examined the frequency of unwanted side effects with this device. The study found that the guided approach was well-tolerated, with minimal issues reported. This suggests that the 3D guided method could be a safer and more comfortable option compared to the traditional technique.

This new approach is still in the testing phase to determine its safety and effectiveness. However, early studies show promising signs that it might be a better way to perform IANBs.12345

Why are researchers excited about this trial?

Researchers are excited about the 3D guided IANB (Inferior Alveolar Nerve Block) because it offers a more precise and targeted approach to dental anesthesia compared to traditional methods. Unlike the conventional nerve block techniques that rely on anatomical landmarks and can sometimes result in inaccurate injections, the 3D guided approach uses advanced imaging to accurately locate the nerve, potentially reducing patient discomfort and increasing the success rate of the block. This innovation could lead to more efficient dental procedures with fewer complications, making it a promising development in dental care.

What evidence suggests that this 3D guided approach is effective for Inferior Alveolar Nerve Block?

Research has shown that the traditional method for numbing the lower jaw, known as the Inferior Alveolar Nerve Block (IANB), fails 30-45% of the time due to difficulty in targeting the correct spot. In this trial, participants will receive the new 3D Guided IANB technique, which aims to improve accuracy by using a device that guides the needle more precisely to the nerve. Computer models suggest this method could achieve 70% to 100% accuracy. Studies have also reported that this new method causes less pain, as indicated by low scores on a pain scale. Thus, the 3D guided approach could be more effective and comfortable for patients.12567

Who Is on the Research Team?

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Tum-Yi Hsu, DMD DScD

Principal Investigator

BU Goldman School of Dental Medicine, Endodontics

Are You a Good Fit for This Trial?

This trial is for patients at the Henry M. Goldman School of Dentistry needing non-surgical endodontic therapy on mandibular molars or premolars, with a specific pulpal diagnosis and no symptoms. They must have at least 3 vital teeth in the quadrant to be treated, require a CBCT scan for clinical reasons, be in good health (ASA1), and agree to receive guided IANB.

Inclusion Criteria

I am a patient at the Henry M. Goldman School of Dentistry.
I am in good health with no serious diseases.
I need a root canal on my lower back tooth.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guided IANB using an IANBD at three injection sites

Single session
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • IANBD 3D guided approach

Trial Overview

The study tests a new 3D printed device that guides anesthesia injections directly to the mandibular foramen during dental procedures. This method aims to increase accuracy compared to traditional techniques, reduce tissue damage, and improve patient comfort by using cone beam computed tomography (CBCT) imaging.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IANBD guided Inferior Alveolar Nerve block (IANB) injectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials
494
Recruited
9,998,000+

Citations

Clinical Application of Inferior Alveolar Nerve Block Device ...

The inferior alveolar nerve block (IANB) is an established technique with a success rate of 60–80%; however, large errors have been reported ...

An in-silico comparison of success rate of different methods ...

This in-silico model reproduced the literature results of the clinical accuracy (70%-100%) of inferior alveolar nerve blockade.

Effectiveness of ultrasound-guided peripheral mandibular ...

This systematic review showed that USG IANB can effectively manage pain in adult patients undergoing specific dental surgical procedures including third molar ...

3D Guided Dental Implant Placement: Impact on Surgical ...

The aim of this in vitro pilot study was to investigate the effect of freehand (FH) and fully guided (FG) surgery on the accuracy of implants placed in close ...

Clinical Application of Inferior Alveolar Nerve Block Device ...

Discomfort with the use of the IANB device was less than 30 mm on the visual analog scale. No notable complications were observed. Te ...

The Optimal Injection Site for a 3D Guided Inferior Alveolar ...

The goal of this research is to to evaluate the acceptability, safety, and effectiveness of guided anesthesia using the IANBD by enrolling 10 ...

Dental Anxiety and Pain During Inferior Alveolar Nerve ...

Objectives: To compare the effectiveness of virtual reality (VR) and external cooling and vibration distraction techniques on dental anxiety ...