Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
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: Head and Neck Cancer, Osteonecrosis, Osteoradionecrosis. Базовые параметры: Без ограничений · 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction
Подробное описание
The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
Первичные конечные точки
- implant survival rate [Срок оценки: within 12 months postoperative]
- bone resorption, as evaluated with cone-beam computed tomography [Срок оценки: within 12 months postoperative]
- prosthesis survival rate [Срок оценки: within 12 months postoperative]
- implant survival rate [Срок оценки: within 60 months postoperative]
- bone resorption, as evaluated with cone-beam computed tomography [Срок оценки: within 60 months postoperative]
- prosthesis survival rate [Срок оценки: within 60 months postoperative]
Вторичные конечные точки (3)
- Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ [Срок оценки: within 12 months postoperative]
- Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis [Срок оценки: within 60 months postoperative]
- Patient' quality of life after prosthetic rehabilitation [Срок оценки: until a maximum of 60 months follow-up]
Критерии участия
Критерии включения
- Patients of all ages
- Patients of all genders
- Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring segmental or total jaw resection
- Patients eligible for jaw and oral cavity reconstruction combined with immediate/delayed implant loading for fixed prosthetic rehabilitation
- Patients not eligible for conventional removable prosthetic rehabilitation
Критерии исключения
- Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
- Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
- Patients eligible for conventional removable prosthetic rehabilitation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 1 центр
- General Hospital Saint-John Bruges — Bruges
Идентификаторы
NCT: NCT02661139 · B049201525496