Clinical and Periodontal Evaluation of Deep Marginal Elevation for Proximal Carious Lesions Restored with Bioactive Giomer Versus Nanohybrid Resin Composite: Two Years Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Post-operative sensitivity
研究概览
简要总结
This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.
详细描述
Background and rationale:
Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction (CEJ). Deep marginal elevation (DME) or cervical margin relocation (CMR) is a procedure that involves raising the proximal margin of the tooth defect with direct composite to promote isolation and restoration using direct, semi-direct or indirect techniques. A high level of knowledge and clinical expertise are necessary to perform such procedure in a predictable way in addition to meticulous attention to the supracrestal tissue attachment or the biological width which consists of junctional epithelium and supracrestal connective tissue attachment.
Research question:
In young and middle-aged patients having deep subgingival proximal cavities extending below CEJ, will the bioactive Giomer show similar clinical, radiographic and periodontal performance compared to nanohybrid resin composite over 2 years follow up?
Statement of the problem:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young and middle aged patients (20-50)
- •Good or moderate oral hygiene (plaque index 0 or 1 )
- •Patient approval
- •Absence of parafunctional habits and/or bruxism
排除标准
- •Patients with known allergic or adverse reaction to the tested materials.
- •Systematic disease that may affect participation.
- •Xerostomic patients.
- •Patients with active periodontal disease.
- •Heavy smokers
结局指标
主要结局
Post-operative sensitivity
时间窗: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.
次要结局
- Marginal adaptation(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Occurrence of caries(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Proximal Contact(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Plaque Index(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Gingival Index(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Interdental Pressure Index(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Papillary bleeding on probing Index(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Probing Depth(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
- Radiographic examination(Baseline (1 week after intervention), 6 months, 12 months and 24 months)
研究者
Samir Ashraf Fayez Rostom
Principal Investigator
Cairo University