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Набор по приглашению NCT07090772

The Effectiveness of Different Therapeutic Jaw Position Determining Methods in Repositioning Splint Therapy for Temporomandibular Joint Disk Displacement Without Reduction:A Randomized Controlled Clinical Trial

Без фазы С лечением Temporomandibular Disorder (TMD)

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: Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual patient.
Кому может быть актуально
Состояния в реестре: Temporomandibular Disorder (TMD). Базовые параметры: 13 лет — 50 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
Китай
Следующий шаг
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Обзор

The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. The main questions it aims to answer are: Does different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction? Researchers will compare the efficacy of repositioning splint therapy made with different therapeutic jaw position determining methods for temporomandibular joint disk displacement without reduction. Participants will: Take repositioning splint made with different therapeutic jaw position determining methods every day for 3-6 months. Visit the clinic once every 3 weeks for checkups and tests.

Вмешательства

  • Процедура Repositioning splint therapy with jaw position determined by mechanical articulator
    The therapeutic jaw position will be determined by the following steps: 1. Pre-treatment Jaw Position Recording Participants were seated upright with relaxed posture, eyes facing forward, and the Frankfort plane parallel to the floor. Intercuspal position (ICP) was recorded using silicone registration material. Edge-to-edge position of central incisors was recorded for protrusive position. Left/right lateral positions were recorded with opposing canines aligned. 2. Transfer of Jaw Positions Fol
  • Процедура Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator
    The jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Jaw Models CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The mandibular/maxillary bone models and dental arches were exported as .ply files. These .ply files were then imported into Exocad software. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and t
  • Процедура Repositioning splint therapy with jaw position determined by ai-assisted virtual patient
    The jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Virtual Patients: CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The trajectory of mandibular movement was recorded by an electronic facebow. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-se

Первичные конечные точки

  • Condylar position as assessed by CBCT measurements [Срок оценки: 3-6 months]
  • Condylar repositioning rate as assessed by CBCT measurements [Срок оценки: 3-6 months]
Вторичные конечные точки (3)
  • Fricton index as assessed by comprehensive physical examination to participants [Срок оценки: 3-6 months]
  • Dysfunction index as assessed by by comprehensive physical examination to participants [Срок оценки: 3-6 months]
  • Palpation index as assessed by by comprehensive physical examination to participants [Срок оценки: 3-6 months]

Критерии участия

Критерии включения

  • Aged 13-50 years, with permanent dentition, possessing full autonomy in behavior and expression;
  • Meeting the 2014 Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic standards for irreducible temporomandibular joint disc displacement;
  • MRI-confirmed unilateral irreducible disc displacement: At maximum intercuspation: Posterior band of disc located anterior to the 11:30 position, intermediate zone anterior to condyle; At maximum mouth opening: Intermediate zone remains anterior to condyle.

Критерии исключения

  • Systemic diseases, psychiatric disorders, or impaired consciousness;
  • Pain-only disorders without articular pathology signs;
  • Mandibular hypoplasia, TMJ tumors, or prior TMJ trauma;
  • History of definitive TMJ disorder treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Fujian Medical University — Фучжоу

Идентификаторы

NCT: NCT07090772 · 2025ECSS057

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗