Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth

Обзор

This study aims to evaluate the antibacterial effects of injectable platelet-rich fibrin (i-PRF) in vitro, and to assess the clinical and radiographic outcomes of using advanced platelet-rich fibrin (A-PRF+) and i-PRF in regenerative endodontic treatment of mature permanent teeth with necrotic pulp. The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.

Подробное описание

This study aims to evaluate the antibacterial effects of injectable platelet-rich fibrin (i-PRF) in vitro, and to assess the clinical and radiographic outcomes of using advanced platelet-rich fibrin (A-PRF+) and i-PRF in regenerative endodontic treatment of mature permanent teeth (single-rooted teeth with necrotic pulp, with or without periapical pathology). The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.

Вмешательства

• Процедура Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth.
  After obtaining informed consent, the study will be conducted over 2 appointments, 2-4 weeks apart. The first appointment will focus on infection control and inflammation reduction. The canal will be instrumented with a single-file system. The canal will be then irrigated sequentially with 3% sodium hypochlorite (NaOCl), saline, and 17% ethylenediaminetetraacetic Acid (EDTA) to ensure thorough disinfection. Finally, a temporary filling of Glass Ionomer Cement will be placed over an intracanal d

Первичные конечные точки

• Clinical assessment [Срок оценки: 1 month, 3 months, 6 months, 9 months, 12 months.]
• Radiographic assessment [Срок оценки: 1 month, 3 months, 6 months, 9 months, 12 months]

Критерии участия

Критерии включения

Participants had a single-rooted tooth with necrotic pulp (negative response to electric pulp testing), with or without periapical pathology (acute apical periodontitis of pulpal origin, chronic periapical periodontitis, periapical abscess with sinus, periapical abscess without sinus), and gave their consent to participate in the study.

Exclusion Criteria: Study samples will be excluded if any of the following criteria are met:

• The tooth has had previous endodontic treatment.
• The root apex is not fully developed, or there is root resorption/cracking/fracture.
• The tooth has severe tooth loss and is indicated for extraction, or is indicated for restoration with a post or cast core after endodontic treatment.
• The root canal is calcified.
• The root canal curvature is greater than 25º.
• The tooth has a periapical cyst or is associated with a jawbone cyst.
• The tooth has a periodontal pocket deeper than 4 mm.
• The tooth has no occlusal contact.
• The patient is pregnant.
• The patient has diabetes or HIV or other immunocompromised conditions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Odonto-Maxillo-Facial Hospital and University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Идентификаторы

NCT: NCT07192289 · 3787/QĐ-ĐHYD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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