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Идёт набор NCT06843525

Bite Force Measurements

— Наблюдательное Irreversible Pulpitis Apical Periodontitis Pulpal Necrosis

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Irreversible Pulpitis, Apical Periodontitis, Pulpal Necrosis. Базовые параметры: 18 лет — 89 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
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Официальное название

Exploring a Neuropathic Basis for Acute Pulpal Pain- a Clinical Pilot

Обзор

ABSTRACT: Acute dental pain from untreated decay often drives patients to emergency rooms (ERs), where the lack of definitive dental treatment results in nearly 75% of these patients receiving analgesics, predominantly opioids. Addressing the need for non-opioid pain alternatives is crucial. Emerging evidence suggests that dental pain from pulpal and periodontal conditions (affecting the tooth's nerve and surrounding tissues) involves neuropathic mechanisms, such as mechanical allodynia (MA) and central sensitization (CS). These mechanisms can amplify pain perception, causing typically non-painful actions, like chewing, to become painful and resulting in hypersensitivity extending beyond the affected tooth. Reliably identifying these mechanisms with quantitative measures can support improved pain assessment and targeted non-opioid treatment. This minimally invasive prospective cohort study will use the FDA-approved Innobyte® device, a precise bite-force measurement tool, to evaluate periodontal health and to quantify mechanical pain thresholds in patients requiring endodontic treatment (root canal therapy).

Подробное описание

This study aims to validate neuropathic mechanisms as therapeutic targets by quantifying toothache-induced mechanical allodynia. It could potentially support the use of neuropathic pain medications, like gabapentin, as adjuncts to traditional pain management. The study's findings could also reduce opioid reliance in ER settings, particularly benefiting underserved populations with limited access to dental care. This innovative approach challenges conventional views on dental pain and may provide the foundation for future research.

Первичные конечные точки

  • Mechanical Allodynia [Срок оценки: Baseline]
  • Mechanical Allodynia [Срок оценки: 10 minutes post-local anesthesia]
  • Central Sensitization [Срок оценки: Baseline]
  • Central Sensitization [Срок оценки: 10 minutes post-local anesthesia]
Вторичные конечные точки (4)
  • Assessment of tooth vitality [Срок оценки: Baseline]
  • Assessment of tooth vitality [Срок оценки: 10 minutes post-local anesthesia]
  • Numerical Pain Rating Score [Срок оценки: Baseline]
  • Numerical Pain Rating Score [Срок оценки: 10 minutes post-local anesthesia]

Критерии участия

Критерии включения

  • Individuals who present for
  • a lower 1st or 2nd molar filling in an otherwise healthy tooth, i.e., does not have large decay that has already infected the nerve of the tooth, or there is increased mobility due to gum disease or a root canal treatment on a lower molar tooth and there is no history of injury to the tooth, or
  • a lower molar root canal treatment, and
  • are 18 years or older
  • capable of providing informed consent, are eligible to participate in the study, as long as they satisfy the criteria below.
  • The opposing tooth is present, symptom-free and has adequate tooth structure that allows it to make contact with the tooth it bites against, and
  • are English-speaking

Критерии исключения

  • Any patient, even if satisfying the criteria above, may not take part if any of the below is true:
  • Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
  • Take prescription pain medications for long-standing health conditions
  • Addiction/ substance dependence
  • Swelling that extends beyond the tooth in question
  • Are already taking an antibiotic to treat an infection/swelling
  • Missing complementary molar on the same or opposite side of the mouth
  • Missing more than 2 teeth in a quadrant (other than 3rd molars)
  • Any other molar in the pair either on the side of the tooth of interest or the molar pair on the other side is painful to biting pressure or upon 'tapping' the tooth with the handle of the mouth mirror
  • The patient has taken a pain medication within the last 6 hours

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Rutgers School of Dental Medicine — Newark

Идентификаторы

NCT: NCT06843525 · Pro2024002660

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗