Comparison of Conventional and 3D-printed Surgical Obturators for Maxillary Defects
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: Obturator block, Obturator block, Obturator block.
- Кому может быть актуально
- Состояния в реестре: Maxillary Defect Reconstruction. Базовые параметры: 36 лет — 68 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
- Египет
- 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
Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
Обзор
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. A total of 24 patients with acquired maxillary defects will be randomly assigned to receive one of three obturator designs: (1) conventional obturators retained with clasps and wire, (2) resin 3D-printed obturators with printed clasps and palatal screws, or (3) metallic 3D-printed obturators with metal clasps and palatal screws. Patient satisfaction will be evaluated using the Obturator Functioning Scale (OFS), and postoperative complications such as discomfort, lack of retention, or mucosal irritation . The study seeks to determine whether digital fabrication and enhanced retention methods improve clinical outcomes compared to traditional approaches
Подробное описание
Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications.
Recent advancements in digital technology, including intraoral scanning and cone beam computed tomography (CBCT), allow for the precise design and 3D printing of obturators customized to the anticipated defect. Enhanced retention strategies such as palatal screws and custom clasps may offer improved stability, function, and comfort compared to conventional designs.
This randomized controlled clinical trial aims to evaluate and compare the clinical performance of three types of immediate surgical obturators in patients undergoing maxillectomy. A total of 24 patients with acquired maxillary defects and sufficient remaining dentition will be randomly assigned to one of three groups:
Group I: Conventional obturators retained with clasps and wire
Group II: Resin 3D-printed obturators with printed clasps and palatal screws
Group III: Metallic 3D-printed obturators with metal clasps and palatal screws
The study's primary outcome is patient satisfaction, assessed using the Obturator Functioning Scale (OFS), which evaluates prosthesis-related comfort, appearance, speech, and function. Secondary outcomes include postoperative prosthetic complications such as pain, ulceration, poor fit, or dislodgement. Assessments will be conducted during the standard healing period.
This study will provide valuable insights into the impact of digital workflows and retention techniques on the functional performance and patient-centered outcomes of obturator prostheses following maxillectomy. Ethical approval has been obtained, and all participants will provide informed consent prior to inclusion.
Вмешательства
- Устройство Obturator block
A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy. - Устройство Obturator block
A digitally designed obturator based on fused CBCT and intraoral scan data. Fabricated in resin using 3D-printing, and retained with 3D-printed clasps and palatal screws. Delivered immediately post-maxillectomy - Устройство Obturator block
A digitally designed and 3D-printed obturator fabricated in metal, using CBCT and intraoral scan data. Retention is provided by metal clasps and palatal screws. Delivered during or immediately after surgery.
Первичные конечные точки
- patient satisfaction [Срок оценки: 2-3 weeks after surgery]
Вторичные конечные точки (1)
- complications [Срок оценки: 2-3 weeks after surgery]
Критерии участия
Критерии включения
- Patients indicated for maxillectomy with the remaining number of teeth
- Referral to Maxillofacial Prosthodontic Unit, Mansoura University
Критерии исключения
- contraindication to surgery (not physically fit to underwent surgery)
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University — Al Mansurah
Идентификаторы
NCT: NCT07079163 · A04011024RP