Titanium-Prepared Platelet-Rich Fibrin for Extraction Socket Healing (TPRF-SOCKET)
Effect of Titanium-Prepared Platelet-Rich Fibrin on Extraction Socket Healing: A Randomized Clinical Trial Using CBCT-Based Volumetric Analysis
Alveolar ridge preservation after tooth extraction is important for maintaining bone volume and facilitating future implant placement. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate that may enhance soft and hard tissue healing through the sustained release of growth factors. However, clinical evidence regarding its effect on socket healing remains limited.
The aim of this prospective randomized controlled clinical trial is to evaluate the effect of T-PRF on alveolar socket healing following tooth extraction. Participants requiring tooth extraction and subsequent implant placement are randomly assigned to either a T-PRF group or a spontaneous healing (control) group. Cone-beam computed tomography (CBCT) is used to evaluate socket healing volumetrically. The primary outcome is the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes include baseline socket volume and postoperative clinical healing.
The findings of this study are expected to provide evidence regarding the effectiveness of T-PRF in enhancing alveolar socket healing and preserving ridge dimensions before implant placement.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Tooth extraction is commonly followed by physiological alveolar bone resorption, which may compromise subsequent implant placement. Alveolar ridge preservation techniques have been developed to minimize post-extraction dimensional changes. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate prepared in titanium tubes without anticoagulants and has been proposed to enhance wound healing and bone regeneration through the sustained release of growth factors.
This prospective randomized controlled clinical trial was conducted at the Department of Periodontology, Eskişehir Osmangazi University. Patients requiring tooth extraction followed by implant placement were screened according to predefined inclusion and exclusion criteria and provided written informed consent before participation.
Participants were randomly allocated to either the T-PRF group or the spontaneous healing (control) group. In the intervention group, T-PRF was prepared from autologous venous blood using titanium tubes and placed into the extraction socket immediately after atraumatic tooth extraction. In the control group, extraction sockets were allowed to heal spontaneously without the use of any socket preservation material. All surgical procedures were performed by the same experienced operator, and postoperative care was standardized for all participants.
Cone-beam computed tomography (CBCT) scans were obtained approximately 10 days after extraction (baseline) and again at 3 months before implant placement. Volumetric measurements were performed using dedicated imaging software by a blinded examiner. The primary outcome was the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes included baseline socket volume and clinical healing during the postoperative period.
The results of this study will contribute to the clinical evidence regarding the effectiveness of T-PRF as a minimally invasive autologous biomaterial for enhancing extraction socket healing prior to implant placement.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Eskişehir, Турция (Туркие), 26140
- Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Systemically healthy individuals.
- Indication for tooth extraction followed by implant placement.
- Adequate bone volume for future implant placement without the need for advanced augmentation procedures.
- Good oral hygiene (Plaque Index ≤1.5)
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Current smokers.
- Pregnant or breastfeeding women.
- Uncontrolled systemic disease or diabetes mellitus.
- Use of medications known to affect bone metabolism.
- History of head and neck radiotherapy or chemotherapy.
- Acute infection, periapical lesions, alveolar bone pathology, or socket defects at the extraction site.
- Severe periodontal destruction requiring extensive augmentation procedures.
- Inability or unwillingness to attend scheduled follow-up visits.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: T-PRF Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket.
Standard postoperative care was provided, and healing was evaluated over a 3-month follow-up period.
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Autologous titanium-prepared platelet-rich fibrin (T-PRF) was prepared from the participant's venous blood collected into sterile titanium tubes without anticoagulant and centrifuged immediately after blood collection.
The resulting fibrin clot was separated from the red blood cell layer, compressed into a membrane, and placed into the extraction socket immediately after atraumatic tooth extraction.
The socket was then stabilized with sutures according to the study protocol.
Другие имена:
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Без вмешательства: Control Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket.
Standard postoperative care was provided, and healing was evaluated during a 3-month follow-up period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Socket Fill
Временное ограничение: 3 months after tooth extraction
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Percentage of socket fill calculated using CBCT-based volumetric analysis by comparing the baseline socket volume with the residual non-ossified socket volume after healing.
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3 months after tooth extraction
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Percentage of Socket Fill
Временное ограничение: 3 months after tooth extraction
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Percentage of socket fill calculated from CBCT-based volumetric measurements by comparing baseline socket volume with the residual non-ossified socket volume after 3 months.
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3 months after tooth extraction
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: hakan özdemir, proffesor, Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- ESOGU-TPRF-2023-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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