Effectiveness of RMGI and Giomer, Both Individually and in Combination, for Restoring Anterior Cervical Caries in High-Risk Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Secondary Caries
研究概览
简要总结
This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.
详细描述
This study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. The research will compare resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer (lamination technique). The randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. The primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. Assessments will occur at baseline, 6, 12, and 18 months using modified USPHS criteria.
The rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. The bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. The research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. The study is self-funded and will be conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with appropriate ethical approvals and informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors (A.Y. & D.E.), who are experienced clinicians responsible for evaluating the restorations at each follow-up period (baseline, 6, 12, and 18 months), are kept completely unaware of which treatment each patient received. They evaluate all restorations using standardized criteria without knowledge of the group allocation. Additionally, the statistician who analyzes the collected data is also blinded to the treatment groups during the statistical analysis process, ensuring unbiased interpretation of results.
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age range from 18-55 years
- •Presence of anterior cervical caries on the labial surface (ICDAS 4 & 5)
- •High caries risk
- •Good general health
排除标准
- •Severe or chronic periodontal disease
- •Non-vital teeth
- •Fractured or cracked teeth
- •Defective restorations
- •Pregnancy and/or lactation
- •Allergy to the main components of the products to be used in the study
研究组 & 干预措施
Group 2 (RMGI + Giomer Lamination)
Cavities will be restored using a combination technique where light-cured resin modified glass ionomer (GC Fuji II LC) is applied first, leaving 1.5mm space for Giomer. After selective enamel etching, adhesive will be applied to both enamel and dentin margins as well as the RMGI floor, followed by application of Beautifil II LS Giomer as the final layer.
干预措施: RMGI alone - Control (Procedure)
Group 3 (RMGI alone - Control)
Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured. GC Fuji Varnish will be applied before and after finishing to prevent moisture penetration.
干预措施: Low shrinkage Giomer restorative material (Beautifil II LS) (Procedure)
Group 1 (Giomer)
Cavities will be restored with low shrinkage Giomer restorative material (Beautifil II LS, Shofu, Japan). After etching enamel margins with 37% phosphoric acid for 15 seconds, FL bond two-step self-etch adhesive will be applied, followed by incremental application of Giomer (maximum 2mm thickness) with light-curing for 20 seconds.
干预措施: RMGI alone - Control (Procedure)
结局指标
主要结局
Secondary Caries
时间窗: 18 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Secondary Caries
时间窗: 6 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Secondary Caries
时间窗: 12 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
次要结局
未报告次要终点
研究者
Mahmoud Magdy Eldamanhoury
Assistant Lecturer
Cairo University
