Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses
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: AM manufacturing method, SM manufacturing method.
- Кому может быть актуально
- Состояния в реестре: Dental Prosthesis, Implant-Supported. Базовые параметры: от 20 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, Швейцария
- 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
Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)
Обзор
This research is being done to evaluate the clinical, technical, biological, and aesthetic results of two different fabrication methods (additive and subtractive) for creating implant-supported fixed dental prostheses (iFDPs). Patients will receive an iFDP, meaning an implant-supported crown, according to regular treatment protocols. The fabrication method used to create the implant-supported crown will be decided in a randomised way. Clinical and radiological examinations will be performed prior to and when receiving the implant-supported crown and during a follow-up period of 3 years. Furthermore, technician- and patient-reported outcomes will be evaluated used questionnaires.
Подробное описание
This study is designed as a randomised controlled clinical trial with a multi-centre design. Patients in need of a definitive posterior implant-supported crown will be enrolled in this study following predefined eligibility criteria at two different study centres (Harvard School of Dental Medicine, Harvard University and Center of Dental Medicine, University of Zurich). Patients will receive a single implant-supported crown fabricated according to group allocation (additively or subtractively manufactured). After crown delivery, patients will be followed-up for an observation period of 3 years. The primary outcome is the clinical performance of the implant crowns. Clinical, technical, biological, and aesthetic results as well as the technician- and patient-reported outcomes will be assessed.
Вмешательства
- Устройство AM manufacturing method
additively manufactured implant-supported prostheses - Устройство SM manufacturing method
subtractively manufactured implant-supported prostheses
Первичные конечные точки
- Clinical success [Срок оценки: This outcome will be evaluated at the baseline and at the follow-up visits after 1 year, 2 years and 3 years]
Вторичные конечные точки (11)
- Efficiency during manufacturing (dental technician) (time) [Срок оценки: Periprocedural]
- Efficiency during manufacturing [Срок оценки: Periprocedural]
- Chairside adjustment time [Срок оценки: Periprocedural]
- Survival rate [Срок оценки: This outcome will be reported on the baseline visit and the follow-up visits after 1, 2 and 3 years]
- Probing Depth [Срок оценки: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Esthetic outcomes [Срок оценки: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Technical outcomes [Срок оценки: this outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Patient-reported outcomes [Срок оценки: This outcome will be assessed at the baseline and follow-up visits after 1, 2 and 3 years]
- Adverse events [Срок оценки: through study completion. This outcome will be reported at baseline and follow-up visits after 1, 2 and 3 years.]
- Bleeding on probing (BOP) [Срок оценки: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Plaque control record [Срок оценки: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
Критерии участия
Критерии включения
- Signed Informed Consent Form in English language
- ≥ 20 years of age
- In need of at least one definitive screw retained premolar or molar iFDP on an existing dental implant (Straumann AG)
- Presence of at least one adjacent tooth at the implant site
- Adequate oral hygiene
- Capability to comply with the study procedures
Критерии исключения
- Pregnant or lactating women
- Known or suspected non-compliance, drug or alcohol abuse
- Severe periodontal and peri-implant disease
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
США · 1 центр
- Harvard School of Dental Medicine — Boston
Швейцария · 1 центр
- Center of Dental Medicine, University of Zurich — Zurich
Идентификаторы
NCT: NCT07090863 · 3DP-Implant-Crown