Comparative Evaluation of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic Versus Non-Diabetic Patients Using Modified USPHS Criteria: An 18-Month Non-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Restoration Retention Score Assessed Using Modified USPHS Criteria
研究概览
简要总结
Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries.
This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
- •Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
- •Non-diabetic patients with no systemic diseases (for control group).
- •Teeth indicated for Class V composite restoration.
排除标准
- •Uncontrolled diabetes mellitus.
- •Patients with other systemic diseases affecting oral health.
- •Teeth with pulpal involvement or requiring endodontic treatment.
- •Patients with parafunctional habits. Pregnant or lactating women
研究组 & 干预措施
Diabetic Patients
Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin
干预措施: Giomer-based composite restoration (Device)
Non-Diabetic Patients
Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol.
干预措施: Giomer-based composite restoration (Device)
结局指标
主要结局
Restoration Retention Score Assessed Using Modified USPHS Criteria
时间窗: Baseline, 6 months, 12 months, and 18 months
Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time.
次要结局
- Marginal Adaptation Score Assessed Using Modified USPHS Criteria(Baseline, 6 months, 12 months, and 18 months)
- Secondary Caries Score Assessed Using Modified USPHS Criteria(Baseline, 6 months, 12 months, 18 months)
- Marginal Discoloration Score Assessed Using Modified USPHS Criteria(Baseline, 6 months, 12 months, 18 months)
- Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria(Baseline, 6 months, 12 months, 18 months)
研究者
Radwa Wael Maher
Lecturer Assistant
Cairo University