Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment

Официальное название

A Multicenter, Randomized Controlled, Single-blind, Non-inferiority Clinical Trial of Modified Endocrown and Personalized Post Core Combined With Full Crown for Large-area Tooth Defects After Root Canal Treatment

Обзор

This study intends to adopt a multicenter, randomized controlled, single-blind, non-inferiority clinical trial design. 246 premolars that meet the inclusion criteria after complete root canal treatment will be selected from the clinical practice and randomly divided into two groups. One group will be restored with the modified endocrown, and the other group will be restored with personalized post and core combined with full crown. Follow-up visits were conducted at 6 months, 1 year and 2 years after the operation respectively. Through clinical and imaging examinations, the survival rates of the two different restorations were evaluated and used as the main evaluation indicators to fill the gap in efficacy data of the modified endocrown in clinical applications, providing a strong evidence-based medical basis for subsequent restoration improvement and standardized application.

Вмешательства

• Процедура modified endocrown
  Combining the advantages of post-core crown and endocrown, an modified endocrown was designed

Первичные конечные точки

• survival rate [Срок оценки: 6 month、1 year、2 years]

Вторичные конечные точки (3)

• Tooth reserve volume [Срок оценки: immediately]
• patient satisfaction [Срок оценки: 2 years]
• Adjust the amount of grinding tissue and the time of occlusal adjustment [Срок оценки: immediately]

Критерии участия

Критерии включения

• 1: The affected tooth was a premolar that had undergone complete root canal treatment for two weeks. Both imaging and clinical examinations indicated no abnormal periapical reactions.

2: The oral hygiene condition is good. There is no periodontitis or combined periodontal and endodontic lesions with a probing depth greater than 4mm. There are no severe oral bad habits (such as smoking more than 20 cigarettes per day, chewing betel nuts, etc.)

3: At least 50% of the crown structure should be retained, or at least two crown walls should be retained, and the tooth defect should not be located under the gums or can be aligned with the gums or located above the gums through crown lengthening surgery.

4: The affected tooth has sufficient root length to ensure a pedicle-crown ratio of at least 1:1 and a root tip closure of at least 3 mm.

5: The occlusal function is normal.

6: Treated premolars will not be used as abutments for FPD or RPD restoration.

Критерии исключения

• 1: Root canal retreatment of the affected tooth.

2: Loosening > I °, alveolar bone resorption exceeds 1/3 of the root length.

3: Loss of adjacent teeth and occlusal teeth.

4: The patient is in the preconception period and the pregnancy period.

5: Patients with night bruxism, deep overbite, tight occlusion or severe limited mouth opening, and temporomandibular joint diseases.

6: Patients who have a history of chemotherapy or radiotherapy in the head and neck region within 5 years, suffer from severe systemic and organic diseases, have physical disabilities or mental illnesses that affect oral hygiene care, or have received drug treatment that may affect or promote bone metabolism within the past 3 months.

7: The affected tooth has imaging manifestations of absorption inside and outside the root, or the anatomical morphology of the root and root canal is poor, such as short and small roots, curved root canals, small roots or residual roots that cannot meet the cord-to-root ratio standard for pile-core crown restoration.

8: The researchers consider other situations that are not suitable for participation.

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

• Nanfang Hospital of Southern Medical University — China

Идентификаторы

NCT: NCT07206108 · NFEC-2025-270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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