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Идёт набор NCT06619574

Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.

Без фазы С лечением Temporomandibular Joint Syndrome

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: 3D Analysis Group, Manual Analysis Cohort.
Кому может быть актуально
Состояния в реестре: Temporomandibular Joint Syndrome. Базовые параметры: 18 лет — 90 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 →
Официальное название

Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison

Обзор

This study is being performed to determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs).

Подробное описание

Standard practice in the treatment of temporomandibular dysfunction (TMD) currently involves non-radiographically-assisted manual repositioning of the jaw followed by either an in-office cone beam computerized tomography (CBCT) or tomographic X-ray of both TMJs, and further adjustment as necessary to improve the initial bite impression.\[15\] At follow up visits the therapeutic splint is modified in stages to "walk" the condyle progressively into the ideal position, such as altering side shift, lateral deviation, and rotation. During this process multiple CBCTs or tomographic X-rays, and multiple direct dentist interventions, are required to find the precise joint position, involving significant radiation exposure, and significant chair time for the dentist

The key advantage of using the Dental Compass Articulator in conjunction with its software, is to identify and suggest corrections for the range of orthopedic imbalances present. Software-facilitated identification of imbalances is coupled with manipulation of yaw (anterior, posterior, lateral, or rotational movement of the mandible in a horizontal plane), pitch (rotation of the mandible in a frontal vertical plane), and roll (rotation of the mandible in a lateral vertical plane) to achieve optimal condylar and mandibular position for splint manufacture.

The goals of this study are to:

1. Determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, and will compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs), and 2. Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.

Вмешательства

  • Устройство 3D Analysis Group
    Dental Compass and Dental Compass software used for therapeutic splint fabrication
  • Другое Manual Analysis Cohort
    Manual methods used for therapeutic splint fabrication

Первичные конечные точки

  • Number of clinic visits [Срок оценки: 3-6 months]
  • Number of cone beam CTs (CBCTs) [Срок оценки: 3-6 months]
  • Number of splint modifications [Срок оценки: 3-6 months]
Вторичные конечные точки (5)
  • Gelb 4/7 position achieved during treatment (3D group only) [Срок оценки: 3-6 months]
  • Anterior joint space of 1.8 mm or more achieved during treatment (3D group only) [Срок оценки: 3-6 months]
  • Posterior joint space of 1.8 mm or more achieved during treatment (3D group only) [Срок оценки: 3-6 months]
  • Improvement in total airway volume [Срок оценки: 3-6 months]
  • Improvement in minimum airway diameter [Срок оценки: 3-6 months]

Критерии участия

Inclusion Criteria for prospective active participants:

  • TMJ dysfunction and pain
  • CBCT indicates a non-Gelb 4/7 position or < 1.8 mm bone to bone interval between the mandibular condyle and mandibular fossa anteriorly or posteriorly.

Критерии исключения

  • Planning a move within 9 months.
  • Unwilling to provide two phone numbers and two email contacts.
  • Not willing to express a willingness to come in for 4-6 month follow up if they have marked improvement or improvement in symptoms.
  • Not living within 90-minute drive from clinic
  • Transportation not reliable
  • Involved in any other TMD study
  • Life threatening illness or major surgery planned
  • Other major life stress that might interfere with completing the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Skalff Dental Studio and Technologies 103 C West Broadway Street #3736 — Gainesville

Идентификаторы

NCT: NCT06619574 · Dental Compass - 01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗