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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- IL-18
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
non
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Self-Adhesive Resin Cement Group
In this split-mouth clinical study, stainless steel crowns placed on mandibular second primary molars (tooth 75) were cemented using a self-adhesive resin cement (G-Cem ONE™, GC, Japan). Clinical periodontal parameters (plaque index, gingival index, and bleeding on probing) and gingival crevicular fluid levels of interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were evaluated before treatment and one week after cementation.
干预措施: High-Viscosity Glass Ionomer Cement (Device)
High-Viscosity Glass Ionomer Cement Group
In the contralateral quadrant of the same patients, stainless steel crowns placed on mandibular second primary molars (tooth 85) were cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Clinical periodontal parameters and gingival crevicular fluid cytokine levels (IL-10, IL-12, IL-18) were assessed before treatment and one week after cementation for comparison with the resin cement group.
干预措施: Self-Adhesive Resin Cement Group (Other)
结局指标
主要结局
IL-18
时间窗: Baseline and 1 week post-cementation
IL-18 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
Change in gingival crevicular fluid interleukin-12 (IL-12)levels
时间窗: Baseline and 1 week post-cementation
IL-12 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
Change in gingival crevicular fluid interleukin-10 (IL-10) levels
时间窗: Baseline and 1 week after cementation
IL-10 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
次要结局
未报告次要终点
研究者
Özgür Doğan
Associate Prof.
Afyonkarahisar Health Sciences University