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Идёт набор NCT07457749

Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth

Ранняя фаза I С лечением Proximal Cavities of Posterior Teeth

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: Stela, SDI, Australia, Beautifil II, Shofu, Japan.
Кому может быть актуально
Состояния в реестре: Proximal Cavities of Posterior Teeth. Базовые параметры: 18 лет — 47 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 Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial

Обзор

The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.

Вмешательства

  • Препарат Stela, SDI, Australia
    Stela, (SDI ) is a novel self-cured bulkfill dental restorative material that is used in combination with an adhesive primer (Stela primer) which doesn't require light curing but it undergoes polymerization upon contact with the restorative material.
  • Препарат Beautifil II, Shofu, Japan
    Beautifil II is a light-cured bioactive nanohybrid resin composite restorative material. It is a renowned Giomer (Glass-ionomer/composite hybrid) restorative material from Shofu. It is famous for its "S-PRG" (Surface Pre-Reacted Glass) technology, which allows it to release and recharge fluoride like a glass ionomer while maintaining the aesthetics and durability of a composite.

Первичные конечные точки

  • Proximal contact tightness of examined class II restorations [Срок оценки: Baseline (after 1 week) and at 6, 12, 18, 24 months]
Вторичные конечные точки (1)
  • Postoperative Hypersensitivity [Срок оценки: Immediate post procedure and after 1 week]

Критерии участия

Критерии включения

  • Subjects between the ages of 18-47 years old
  • Primary caries removal
  • Good or moderate oral hygiene
  • Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
  • Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance

Критерии исключения

  • Composite or amalgam removal
  • Caries extended to the cemento-enamel junction in Class II caries
  • Grade II or III mobility
  • Considerable periodontal disease without treatment
  • Endodontically treated teeth with extensive loss of tooth tissues
  • Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism.
  • Subjects who are pregnant during the duration of the study
  • Subjects with high caries activity

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of Dentistry, The British University in Egypt — Cairo

Идентификаторы

NCT: NCT07457749 · 25-069 · Self-funded

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗