DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 18 LEVELS IN GINGIVAL CREVICULAR FLUID
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: Self-Adhesive Resin Cement Group, High-Viscosity Glass Ionomer Cement.
- Кому может быть актуально
- Состояния в реестре: Dental Caries, Gingival Inflammation, Periodontal Response to Dental Restorative Materials. Базовые параметры: 6 лет — 10 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
- Turkey (Türkiye)
- 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
Determination of the Effects of Stainless Steel Crowns Cemented With Resin Cements on Interleukin-10, Interleukin-12, and Interleukin-18 Levels in Gingival Crevicular Fluid
Обзор
This split-mouth clinical study aimed to evaluate the early effects of stainless steel crowns cemented with self-adhesive resin cement and high-viscosity glass ionomer cement on clinical periodontal parameters and interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) levels in gingival crevicular fluid in pediatric patients. The study included 45 systemically healthy children aged 6-10 years. Stainless steel crowns were placed on the mandibular second primary molars (teeth 75 and 85) in each patient; tooth 75 was cemented with a self-adhesive resin cement (G-Cem ONE™, GC, Japan), while tooth 85 was cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Plaque index, gingival index, and bleeding on probing were recorded before treatment and one week after cementation. Gingival crevicular fluid samples were collected at the same time points, and IL-10, IL-12, and IL-18 levels were analyzed using the ELISA method. A statistically significant reduction in plaque index values was observed in both cement groups at the one-week follow-up (p\<0.001), whereas no significant differences were found in gingival index or bleeding on probing values (p\>0.05). IL-10 and IL-12 levels did not change significantly in either group, whereas IL-18 levels decreased significantly in the resin cement group and were significantly higher in the glass ionomer cement group postoperatively. These findings suggest that although different cementation materials used for stainless steel crowns yield similar short-term clinical periodontal outcomes, material-related differences may exist in gingival biological responses, particularly with respect to IL-18 levels.
Подробное описание
Stainless steel crowns (SSCs) are widely used in pediatric dentistry for the restoration of severely decayed primary molars due to their durability, cost-effectiveness, and full coronal coverage. Despite their extensive clinical use, concerns remain regarding their potential effects on periodontal tissues, particularly in relation to gingival inflammation and biological responses associated with different luting cements. Resin-based cements and glass ionomer-based materials are commonly used for cementation of SSCs; however, their comparative effects on gingival inflammatory biomarkers have not been fully clarified.
This split-mouth clinical study was designed to evaluate the early periodontal and biological effects of stainless steel crowns cemented with two different materials: a self-adhesive resin cement and a high-viscosity glass ionomer restorative cement. The study included systemically healthy pediatric patients aged 6-10 years requiring stainless steel crown restoration of bilateral mandibular second primary molars. Each participant received two crowns under standardized clinical conditions, allowing intra-individual comparison of the two cementation materials.
Clinical periodontal parameters, including plaque index, gingival index, and bleeding on probing, were recorded before treatment and one week after crown cementation. In addition, gingival crevicular fluid samples were collected at the same time points to evaluate inflammatory cytokine levels. Interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were selected as biomarkers because of their roles in inflammatory regulation and immune response in periodontal tissues. Cytokine levels were analyzed using enzyme-linked immunosorbent assay (ELISA) techniques.
The primary objective of the study was to assess whether the type of cement used for stainless steel crowns influences gingival inflammatory response during the early postoperative period. Secondary objectives included evaluation of short-term clinical periodontal outcomes associated with these restorative procedures.
Understanding the biological effects of various cementation materials may help optimize restorative strategies in pediatric dentistry, improve periodontal tissue compatibility, and inform evidence-based selection of luting materials for stainless steel crowns. The findings of this study may provide clinically relevant information regarding both periodontal health and biomarker responses following stainless steel crown placement in children.
Вмешательства
- Другое Self-Adhesive Resin Cement Group
Stainless steel crowns were placed on mandibular second primary molars in systemically healthy children aged 6-10 years using a split-mouth design. After standard tooth preparation and crown adaptation, cementation was performed using two different luting materials. In one quadrant, crowns were cemented with a self-adhesive resin cement (G-Cem ONE™, GC, Japan), which provides chemical adhesion without the need for separate etching or bonding procedures. In the contralateral quadrant, crowns were - Устройство High-Viscosity Glass Ionomer Cement
A high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan) was used for cementation of stainless steel crowns according to standard clinical procedures.
Первичные конечные точки
- IL-18 [Срок оценки: Baseline and 1 week post-cementation]
- Change in gingival crevicular fluid interleukin-12 (IL-12)levels [Срок оценки: Baseline and 1 week post-cementation]
- Change in gingival crevicular fluid interleukin-10 (IL-10) levels [Срок оценки: Baseline and 1 week after cementation]
Критерии участия
Критерии включения
Children aged 6-10 years
Systemically healthy pediatric patients
Presence of bilateral mandibular second primary molars (teeth 75 and 85) requiring stainless steel crown restoration
Absence of clinical signs of active periodontal disease
Cooperative behavior sufficient to allow dental treatment and gingival crevicular fluid sampling
Written informed consent obtained from parents or legal guardians
Критерии исключения
Presence of systemic diseases or medical conditions affecting periodontal health or immune response
Use of antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last month
Poor oral hygiene or untreated periodontal disease
Teeth with pulpal pathology, mobility, or advanced root resorption
History of allergy to dental materials used in the study
Lack of parental consent or inability to complete follow-up examination
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Afyonkarahisar Health Science University — Afyonkarahisar
Идентификаторы
NCT: NCT07421206 · 2025HATICE · AFSU SCIENTIFIC RESEARCH COORD