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Набор скоро начнётся NCT07648979

3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.

Без фазы С лечением Dental Caries

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: 3D printed resin based crowns, Prefabricated stainless steel crowns.
Кому может быть актуально
Состояния в реестре: Dental Caries. Базовые параметры: 4 лет — 8 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
Египет
Следующий шаг
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Официальное название

Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are: Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types? Participants will: Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy. Attend follow-up visits for clinical evaluation over 12 months.

Подробное описание

primary mandibular molars will be randomly assigned to receive either 3D-printed resin-based crowns or stainless steel crowns. Following pulp therapy and crown placement, participants will attend follow-up visits over a 12-month period. Clinical evaluation will be performed to assess gingival health, plaque accumulation, crown retention, and child and parent satisfaction, in order to determine whether 3D-printed resin-based crowns can be an effective esthetic alternative to stainless steel crowns.

Вмешательства

  • Устройство 3D printed resin based crowns
    1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth. 2-Perform occlusal reduction of approximately 1.5-2.0 mm following the natural occlusal anatomy. 3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance. 4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm. 5-Avoid creating ledges or damaging adjacent teet
  • Устройство Prefabricated stainless steel crowns
    1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth. 2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement. 3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper. 4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating. 5-Round sharp line angles a

Первичные конечные точки

  • Gingival index [Срок оценки: baseline, 3 months, 6 months, 9 months, 12 months]
Вторичные конечные точки (3)
  • Plaque accumulation [Срок оценки: baseline, 3 months, 6 months, 9 months, 12 months]
  • Child and parent satisfaction [Срок оценки: Immediately post operative]
  • Crown retention [Срок оценки: baseline, 3 months, 6 months, 9 months, 12 months]

Критерии участия

Критерии включения

Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.

Parents/guardians willing to provide written informed consent and attend follow-up visits.

Критерии исключения

Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).

Parents/guardians unwilling to participate in the study or provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of dentistry — Cairo

Публикации

  • Flores F, Silva A, Willig R, Reyes A, Serpa J, Marconcin P, Vieira F, Soares D, Casanova N. Exergames as an Effective Alternative to Real Environmental Tennis Training for Adolescents. Sports (Basel). 2024 Jun 17;12(6):168. doi: 10.3390/sports12060168. PMID 38921862

Идентификаторы

NCT: NCT07648979 · FDCU-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗