Topical Application of PRF Before Radiation Therapy
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: PRF, Natural Healing.
- Кому может быть актуально
- Состояния в реестре: PRF. Базовые параметры: 18 лет — 99 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
- Германия
- 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
Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
Обзор
The primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket. Secondary aim is to monitore the effect on the pain perception.
Подробное описание
Head and neck cancer patients are required for a dental checkup before the beginning of the radiation therapy. During this checkup the patients gets a radiological and clinical examination in order to determine any tooth or alveolar bone bound inflammatory processes. Teeth associated to those conditions, or those which are likely to result in any of this, have to be extracted in order to prevent radiation associated complications such as osteomyelitis or further osteoradionecrosis of the jaw. In order to prevent this illness it is essential to not start before the healing of the post-extraction socket has reached a sufficient state, which is usually around 3 weeks post-extracitonem. To facilitate the healing, recent studies have shown an positive effect by applying PRF and a lower pain perception after surgical tooth removal. So far it is not documented for the prevention of a osteoradionecrosis of the jaw.
The patients who receive two or more tooth extractions before radiation therapy can participate in the study. The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaw(s). Both teeth have to have a similar size (e.g. molar and molar).
Patient and Doctors a blinded, the site of PRF Application is chosen by random. After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot.
During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw. After 7d, 14d, 21d, 30d, the wound healing is recorded until it reached is end in complete epithelization.
3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy. 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site.
Вмешательства
- Процедура PRF
Patients blood is standardized centrifuged and split in to a red-phase (erythrocytes) and white-phase (PRF). The gained PRF is processed to a clot-fort and is inserted into the alveolus. - Процедура Natural Healing
After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.
Первичные конечные точки
- Wound healing between the two sites using the Wound Healing Index [Срок оценки: around 4 Weeks]
Вторичные конечные точки (1)
- PRF and Pain perception [Срок оценки: around 7 days]
Критерии участия
Критерии включения
- Head and neck cancer with planed radiation therapy
- Bilateral tooth extraction
- Similar tooth size
- Atraumatic tooth extractions without flap surgery
- Patients age above 18y of age
Критерии исключения
- Prior radiation therapy in the head and neck area
- Prior and current therapy with bisphosphonates or equivalent modern biologics
- Patients during pregnancy or breastfeeding
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- University of Giessen — Giessen
Идентификаторы
NCT: NCT06406530 · TAPRFPR