Набор по приглашению NCT07704151

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars

Без фазы С лечением Zirconia Crowns

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: Prefabricated Zirconia Crown, Custom-made Zirconia Crowns.
Кому может быть актуально: Состояния в реестре: Zirconia Crowns. Базовые параметры: 7 лет — 13 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: Иордания
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

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial

Обзор

This study aims to compare the clinical performance of Prefabricated Zirconia Crowns (PZCs) with that of Custom-made Zirconia Crowns (CZCs) using enhanced clinical protocols.

Подробное описание

Young permanent molars presenting with gross caries, pulpal treatment or developmental defects often require full coverage restorations. Recently, the Prefabricated Zirconia Crowns (PZCs) have been introduced as a biocompatible and an aesthetically pleasant option with promising outcomes. However, it comes in specific sizes, limited shades and a significant tooth preparation is often required. Custom-made zirconia crowns (CZCs), fabricated using CAD/CAM technology may; offer a favorable aesthetic alternative by ensuring a controlled tooth reduction, precise fit, better aesthetics, and improved retention. Nevertheless, the current evidence concerning its use in young permanent molars remains limited. This study will be a randomised clinical trial that aims to compare the clinical performance of (PZCs) with that of (CZCs) for the restoration of badly carious/destructed young permanent molars in children aged 7-13. Patients will be randomised into two treatment groups using an online block randomisation technique (block size of 6) and sealed-envelope techniques. Clinical parameters: retention, fracture, gingival health and marginal integrity will be evaluated at 3-month, 6-month, and 12-month intervals. In addition, treatment duration, intraoperative patient comfort and immediate postoperative patient satisfaction will be evaluated and compared. The findings of this study are expected to provide evidence on the suitability of CZC for young permanent molars in children. The Null hypothesis is that there is no difference between the two types of crowns in terms of clinical performance and child acceptance.

Вмешательства

Процедура Prefabricated Zirconia Crown
Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement.
Процедура Custom-made Zirconia Crowns
Tooth preparation (1-1.5 mm occlusal, 0.5 to 1.25 mm circumferential, with a shoulder-edge supra-gingival margin), followed by scanning with an intra-oral scanner, then temporisation. A zirconia crown will be produced using CAD-CAM technology and cemented with a self-adhesive resin cement on a different visit.

Первичные конечные точки

Rate of Crown retention [Срок оценки: 3,6 and 12 months]
Rate of chipping and fracture of the crown [Срок оценки: 3,6 and 12 months]
Gingival health [Срок оценки: 3,6 and 12 months]
Clinical crown margin extension [Срок оценки: 3,6 and 12 months]
Radiographic crown margin adaptation [Срок оценки: 6 and 12 months]
Clinical crown margin adaptation [Срок оценки: 3,6 and 12 months]

Вторичные конечные точки (3)

Time taken for intervention [Срок оценки: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.]
Patient satisfaction [Срок оценки: immediately following intervention.]
Patient's comfort [Срок оценки: peri-operatively]

Критерии участия

Критерии включения

Medically fit or with mild systemic illness (ASA I or II).
Children who assent to take part in the study with a valid parental consent
Children who have at least one first permanent molar requiring a full-coverage restoration (indications for placing a crown include: badly destructed/carious molars, or teeth affected by molar-incisor hypomineralisation (MIH))
Maxillary or mandibular fully erupted first permanent molars, regardless of the stage of root development.
A cooperative child that accepts dental treatment (Frankle Behaviour Rating Scale #3 or 4).
Capable of attending all follow-up sessions.