Clinical Performance of Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations of Diabetic and Non Diabetic Patients: 18 Months Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Restoration Retention
研究概览
简要总结
This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.
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 (Participant)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female participants from 22 to 55 years
- •Controlled diabetic and non-diabetic patients consulting the outpatient clinic
- •Patients categorized as moderate or high caries risk
- •Patients willing to provide informed consent
- •Co-operative patients agreeing to participate in the trial Inclusion Criteria for teeth
- •Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5)
- •Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment
排除标准
- •Patients with spontaneous or elicited pain from caries.
- •Systemic illnesses other than diabetes.
- •Severe bruxism/clenching.
- •Temporomandibular joint disorders.
- •Inability to return for recall visits/ Refusal to participate in the study.
- •Pregnancy.
- •heavy smoking.
- •Lack of compliance.
- •Exclusion criteria for teeth
- •Teeth presenting with spontaneous or elicited pain
- •A lack of normal pulp vitality testing
- •Visible or clinical signs of pulpal/periapical inflammation before treatment.
- •Class V carious lesions that are not classified as ICDAS code (4) or ICDAS code (5).
结局指标
主要结局
Restoration Retention
时间窗: Baseline, 6 months, 12 months, and 18 months
Restoration retention assessed using the modified USPHS criteria
次要结局
- Marginal adaptation(Baseline, 6 months, 12 months, and 18 months)
- Marginal discoloration(Baseline, 6 months, 12 months and 18 months)
- Secondary caries(Baseline, 6 months, 12 months and 18 months.)
- Postoperative sensitivity(Baseline, 6 months, 12 months and 18 months.)
研究者
Mohamed Ayman Hamdy Ahmed
Assistant Lecturer
Cairo University