Clinical Evaluation of Different Restorative Materials in Deep Cavities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- World Dental Federation criteria (FDI)
研究概览
简要总结
Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.
详细描述
This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in deep cavities.
The treated patients were called back for controls after one week, six months, and twelve months. Restorations were evaluated clinically according to modified FDI criteria (marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, post-operative sensitivity, secondary caries and periodontal response).
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries.
Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p < 0.05).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients aged 18 and over
- •Patients with good oral hygiene.
- •Vital teeth are to be included in the study.
- •The presence of an antagonist and a contact tooth for the tooth to be restored.
- •Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.
排除标准
- •Patients with a history of bruxism and periodontal disease
- •Patients under 18 years of age
- •Spontaneous pain in the tooth to be restored
- •Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
- •Observation of mechanical perforation during caries cleaning
- •Patients suspected of pregnancy or pregnant
结局指标
主要结局
World Dental Federation criteria (FDI)
时间窗: 1 year
次要结局
未报告次要终点
研究者
Muhammet Karadaş
Clinical Professor
Recep Tayyip Erdogan University Training and Research Hospital