Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial

Официальное название

Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial

Обзор

This study aims to find the best way to use your own healthy wisdom tooth to replace the bad tooth. After transplantation, how to manage the "tooth nerve" (dental pulp) inside the tooth is a key question. Currently, doctors have three different management strategies, but it is not clear which one is most beneficial for long-term success. This study will compare these three strategies: Performing standard root canal treatment (removing the tooth nerve) a few weeks after transplantation. Performing a special procedure to treat and fill the root tip during the transplant surgery, followed by root canal treatment later. Simply trimming the root tip during the transplant surgery, hoping to preserve the vitality of the tooth nerve and thereby avoid subsequent root canal treatment. If you agree to participate, you will be randomly assigned to one of these groups to receive treatment. Afterwards, we will need to schedule regular check-ups for you over a period of 5 years (including X-rays and examinations) to monitor the healing of the transplanted tooth, check for any problems, and assess the status of the tooth nerve. Your participation will help us identify the most effective and long-lasting treatment method, thereby benefiting future patients in similar situations.

Вмешательства

• Процедура Postoperative Root Canal Therapy
  This intervention involves the standard non-surgical root canal treatment of the autotransplanted tooth. It is performed after the surgical transplantation procedure, typically initiated within 2-4 weeks postoperatively. The procedure includes pulp extirpation, biomechanical preparation, disinfection, and obturation of the root canal system using standard techniques and materials (e.g., gutta-percha and sealer).
• Процедура Intraoperative Apical Surgery with Retrograde Filling
  This surgical intervention is performed on the donor tooth during the transplantation procedure, while the tooth is outside the mouth (ex vivo). It consists of: 1) Resection of approximately 3mm of the root apex; 2) Preparation of a retrograde cavity at the resected apex; and 3) Obturation of this cavity with a biocompatible material, such as Mineral Trioxide Aggregate (MTA), to achieve a seal. This is followed by postoperative root canal therapy (as described in Intervention 1).
• Процедура Intraoperative Root-End Resection
  This surgical intervention is performed on the donor tooth during the transplantation procedure, while the tooth is outside the mouth (ex vivo). It involves the resection of approximately 3mm of the root apex only, with the aim of enlarging the apical foramen. Crucially, no retrograde preparation or filling is performed. Postoperatively, no prophylactic (preventive) root canal therapy is planned. The goal is to promote revascularization and survival of the pulp. Remedial root canal therapy is pr

Первичные конечные точки

• Success Rate [Срок оценки: 1 year and 5 years postoperatively]
• Survival Rate [Срок оценки: 1 year and 5 years postoperatively]
• Incidence of Inflammatory Root Resorption [Срок оценки: 1 year and 5 years postoperatively]

Вторичные конечные точки (2)

• Pulp Revascularization/Survival (RER Group) [Срок оценки: Postoperative 3, 6, 12 months, and then annually up to 5 years]
• Radiographic Periodontal Ligament Healing [Срок оценки: Postoperative 3, 6, 12 months, and then annually up to 5 years]

Критерии участия

Критерии включения

• Aged 18-40 years.
• Requires extraction of a non-restorable first or second molar AND possesses a fully developed, morphologically healthy ipsilateral third molar as a donor tooth.
• Willing and able to provide written informed consent.

Критерии исключения

• Presence of acute infection or insufficient bone volume at the recipient site.
• Donor tooth exhibits caries, periapical pathology, or periodontal disease.
• Uncontrolled systemic disease (e.g., diabetes, immunosuppression), pregnancy, or lactation.

Smoking habit of >10 cigarettes per day.

• Inability or unwillingness to comply with the long-term follow-up schedule.

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

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07291531 · 2025-1392

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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