跳至主要内容
临床试验/NCT06676098
NCT06676098招募中不适用

The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial

Boston University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Participant acceptability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Allergy to lidocaine or articaine
  • •Resin allergy
  • •Normal teeth unresponsive to thermal testing (ie calcified chamber)
  • •Prior jaw surgery
  • •Currently pregnant

研究组 & 干预措施

IANBD guided Inferior Alveolar Nerve block (IANB) injection

Experimental

Participants will receive a guided IANB using an IANBD.

干预措施: IANBD 3D guided approach (Procedure)

结局指标

主要结局

Participant acceptability

时间窗: 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.

Safety of IANBD based on number of adverse events

时间窗: 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

时间窗: 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.

Clinician acceptability

时间窗: 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.

次要结局

  • Pulp vitality(baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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