Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching

Официальное название

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching Versus Flowable Giomer Using Standard Bonding Protocol in Carious Cervical Lesions: A Randomized Clinical Trial

Обзор

This randomized clinical trial is to evaluate the clinical performance of the self-adhesive flowable Giomer with and without selective enamel etching compared to flowable Giomer using standard bonding protocol in class V cavity restorations over a period of 18 months.

Подробное описание

Self-adhesive flowable restorative materials have been introduced to simplify clinical procedures by eliminating the need for separate bonding steps. These materials are designed to combine adhesive and restorative functions in a single application, which may reduce technique sensitivity and chairside time. However, the bond strength of self-adhesive materials to enamel and dentin remains a concern, particularly in cervical lesions where reliable adhesion is critical for long-term clinical success Selective enamel etching has been suggested as a technique to improve enamel bonding when using self-adhesive or self-etch materials, as it enhances micromechanical retention without adversely affecting dentin bonding. Previous studies have reported that additional enamel etching may improve marginal adaptation and retention, while preserving the simplified clinical procedure of self-adhesive systems. Nevertheless, the clinical effectiveness of self-adhesive Giomer materials with and without selective enamel etching in high caries-risk patients has not been sufficiently investigated.

Therefore, randomized clinical trials evaluating the performance of these materials in cervical carious lesions are required to determine the most reliable restorative approach in patients with increased susceptibility to caries.

Вмешательства

• Другое Beautifil Flow Plus F00
  Conventional flowable giomer restorative material
• Другое FIT SA after selective enamel etching
  using self-adhesive giomer restorative material after selective enamel etching
• Другое FIT SA
  self-adhesive flowable giomer restorative material

Первичные конечные точки

• Retention [Срок оценки: 18 Months]

Вторичные конечные точки (1)

• Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity [Срок оценки: 18 Months]

Критерии участия

Критерии включения

• Cervical carious lesions in anterior teeth and premolars
• Small to moderate class V carious lesion (ICDAS 3 \& 4).
• Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Критерии исключения

• Cervical carious lesions in molars.
• Deep carious defects (close to pulp, less than 1 mm distance).
• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth, Fractured or cracked teeth.
• Endodontically treated teeth.
• Periodontally affected teeth

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07575646 · Self-Adhesive Giomer

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗