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Набор скоро начнётся NCT06338982

Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars

Без фазы С лечением Impacted Third Molar Tooth Osteotomy Orthognathic Surgery Mandibular Fractures

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: Interoperative wisdom tooth removal in conjunction with BSSO.
Кому может быть актуально
Состояния в реестре: Impacted Third Molar Tooth, Osteotomy, Orthognathic Surgery, Mandibular Fractures. Базовые параметры: 18 лет — 75 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
Дания
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

Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third A Randomized Controlled Trial Assessing Fracture Pattern, Condylar Segment Positioning, Complications and Patient-reported Outcome Measures

Обзор

The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are: • Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal. Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery.

Вмешательства

  • Процедура Interoperative wisdom tooth removal in conjunction with BSSO
    The objective of the present randomized controlled trial is to assess the fracture pattern, condylar segment positioning, frequency of complications, and PROMs following BSSO with or without impacted mandibular third molars. this is illustrated by the fact that the test group had their wisdom teeth removed in connection with the sagittal split of the mandible (the BSSO surgery). Subsequently, all outcome measures are compared with the control group, who had their wisdom teeth removed 6 months pr

Первичные конечные точки

  • Fracture pattern following BSSO with or without impacted third molars [Срок оценки: 1 week after det BSSO surgery]
  • Condylar segment position following BSSO with or without impacted third molars [Срок оценки: 1 week after det BSSO surgery]
  • Oral Health Impact Profile-14 (OHIP-14) [Срок оценки: Hand out questionnaires at the following five times, Enrolment, immediately prior to BSSO, One week after BSSO, One months after BSSO and One-year after BSSO]
  • The Modified Dental Anxiety Scale (MDAS) [Срок оценки: Hand out questionnaires at the following three times, Enrolment, immediately prior to BSSO and One-year after BSSO]
  • Short Form-36 (SF-36) [Срок оценки: Hand out questionnaires at the following five times, Enrolment, immediately prior to BSSO, One week after BSSO, One months after BSSO and One-year after BSSO]
  • PROMs [Срок оценки: Hand out questionnaires at the following two times, One week after BSSO and One months after BSSO.]
Вторичные конечные точки (3)
  • Length of the surgical procedure [Срок оценки: Interoperative in connection with the BSSO surgery]
  • Intraoperative bleeding [Срок оценки: Interoperative in connection with the BSSO surgery]
  • Frequency of intra- and postoperative complications [Срок оценки: One week, one months and one-year after BSSO]

Критерии участия

Критерии включения

  • Patients scheduled for surgical correction of facial deformities involving BSSO or bimaxillary surgery with bilateral asymptomatic impacted mandibular third molars
  • Age between 18 and 75 years

Критерии исключения

  • Fully erupted and well-functioning mandibular third molar
  • Unilateral impacted mandibular third molar
  • Pathology associated with the impacted mandibular third molar
  • BSSO combined with genioplasty
  • Previous mandibular fractures
  • Present neurosensory disturbances of the inferior alveolar nerve
  • Systemic bone disease or arthritis
  • Physical status classification system, ASA Class III or IV, specified patients with severe systemic disease ore patients with severe systemic disease that is constant threat to life
  • Failure to attend the entire observation period

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Дания · 1 центр
  • Aalborg universitets hospital — Aalborg

Идентификаторы

NCT: NCT06338982 · N-20230059

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗