Идёт набор NCT06676098

The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)

Без фазы С лечением Inferior Alveolar Nerve Block

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: IANBD 3D guided approach.
Кому может быть актуально: Состояния в реестре: Inferior Alveolar Nerve Block. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Процедура IANBD 3D guided approach
The IANBD will be used to administer the dental anesthetic 2mm medial to the lingula

Первичные конечные точки

Participant acceptability [Срок оценки: 30 minutes post dental procedure]
Clinician acceptability [Срок оценки: 30 minutes post dental procedure]
Safety of IANBD based on number of adverse events [Срок оценки: at the end of the study, about 2 years]
Safety of IANBD based on type of adverse events [Срок оценки: at the end of the study, about 2 years]

Вторичные конечные точки (1)

Pulp vitality [Срок оценки: baseline, 1 minute, 4 minutes, 7 minutes, 10 minutes, 13 minutes]

Критерии участия

Критерии включения

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