Набор скоро начнётся NCT07091331

3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars

Без фазы С лечением Caries, Dental Caries; Dentin Dental Caries in Children

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: Personalized 3D-printed pediatric ceromer crown, Prefabricated stainless steel crown group.
Кому может быть актуально: Состояния в реестре: Caries, Dental, Caries; Dentin, Dental Caries in Children. Базовые параметры: 4 лет — 9 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: Мексика
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Clinical Evaluation of 3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars

Обзор

The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are: * How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars? * What is the level of satisfaction of the patient with both materials? * What is the level of parental satisfaction with both materials? Study methodology: This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.

Подробное описание

This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months).

Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique.

Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.

Вмешательства

Процедура Personalized 3D-printed pediatric ceromer crown
After primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA)
Устройство Prefabricated stainless steel crown group
Stainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA)

Первичные конечные точки

Plaque index (PI) (Silness and Loe, 1964) [Срок оценки: 12 months]
Gingival Index (GI) (Loe & Silness, 1963) [Срок оценки: 12 months]
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations [Срок оценки: 12 months]

Вторичные конечные точки (2)

Patient satisfaction [Срок оценки: 6 months]
Parental satisfaction [Срок оценки: 6 months]

Критерии участия

Критерии включения

Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
Teeth must have an antagonist and be located in opposing hemiarches.
The affected primary molars must be expected to remain in the mouth for at least 12 months.
The child must be in general good health.
Parents or legal guardians must sign informed consent, and the child must provide assent.
Patient does not come to control appointment or does not want to continue research.