Clinical Evaluation of Low-shrinkage Giomer Resin Composite Versus Resin-Modified Glass Ionomer in Treatment of Cervical Caries Lesions: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical performance
研究概览
简要总结
Management of cervical lesions presents serious problems with any restorative material. The two most common reasons for restoration failure are secondary caries at the tooth-restoration interface and loss of retention. Class V lesions often exhibit a low retentive cavity configuration (C-factor); which is responsible for marginal gaps around the restorations. Cervical margins -lying in either dentin or cementum- show unfavorable bonding performance, besides being usually subgingival where moisture control is difficult. The subgingival margin is not clinically desirable due to difficulty in cleaning and increased biofilm accumulation. Therefore, the selection of the restorative material can be challenging.
Resin composites are known for their high mechanical properties, excellent esthetic properties, and ease of clinical application. However, when compared with glass ionomers, resin composite has no cariostatic effect on tooth structure. In addition, microleakage caused by polymerization shrinkage of resin composite leads to plaque accumulation and secondary caries. On the other hand, resin-modified glass ionomer has many advantages, yet still it has lower weakness and esthetic properties compared to resin composite.
Based on current literature, there is limited evidence comparing clinical performance of low-shrinkage giomer resin composite to resin-modified glass ionomer in the treatment of cervical caries lesions.
This study is conducted to evaluate the clinical performance of low-shrinkage giomer resin composite versus resin-modified glass ionomer in treatment of cervical caries lesions, using both Modified USPHS and Revised FDI criteria. This study will be designed to test the null hypothesis that the low-shrinkage giomer resin composite will have the same clinical performance as resin-modified glass ionomer in cervical restorations, using both Modified USPHS and Revised FDI criteria.
详细描述
The development of cervical lesions in permanent dentition may be related to carious or non- carious origin. Class V caries lesions may occur due to different factors such as poor oral hygiene, dietary habits, or xerostomia.
Management of cervical lesions presents serious problems with any restorative material. The two most common reasons for restoration failure are secondary caries at the tooth-restoration interface and loss of retention. Class V lesions often exhibit a low retentive cavity configuration (C-factor); which is responsible for marginal gaps around the restorations. Cervical margins -lying in either dentin or cementum- show unfavorable bonding performance, besides being usually subgingival where moisture control is difficult. The subgingival margin is not clinically desirable due to difficulty in cleaning and increased biofilm accumulation. Therefore, the selection of the restorative material can be challenging.
In this context, fluoride containing adhesive materials are considered ideal in restoring class V carious lesions. Resin modified glass ionomers (RMGI) are highly recommended in the restoration of cervical lesions. The most important advantages of glass ionomer are its chemical adhesion to the tooth structure, and its fluoride release. However, RMGI has lower weakness and esthetic properties compared to resin composite.
In our study, the comparator material will be light cured resin reinforced glass ionomer restorative. RMGI is recommended to restore carious cervical lesions; especially with its ability to inhibit secondary caries due to its fluoride releasing ability. The main advantage of RMGI is its capability to chemically bond to tooth structure, even in the presence of moist dentin. RMGI reaction can be achieved by both acid-base reaction (induced by glass ionomer component) and polymerization reaction (induced by resin component). Thus, RMGI has better mechanical properties, wear resistance, and improved esthetics compared with conventional glass ionomer. In addition, the coefficient of thermal expansion of glass ionomer which is similar to that of tooth structure, allows for proper marginal adaptation without marginal leakage.
Resin composites have been widely used in dental practice; because of their high mechanical properties, excellent esthetic properties, and ease of clinical application.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with carious cervical lesions in maxillary anterior teeth. Patients with at least 20 teeth under occlusion.
- •Age: 25-50 years.
- •Males or females
- •Asymptomatic vital teeth. No pulp pathology or periapical pathosis
- •Healthy periodontium and favorable occlusion.
- •Good general health
- •Co-operative patients approving to participate in the trial.
排除标准
- •Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- •Parafunctional habits or TMJ disorders
- •Active periodontitis
- •Teeth supporting removable prostheses, or orthodontic appliances.
- •Candidates with parafunction or bruxism.
- •Candidates with systemic diseases or disabilities that may affect participation.
- •Xerostomia.
- •Heavy smoking.
- •Pregnancy.
- •Lack of compliance.
结局指标
主要结局
Clinical performance
时间窗: 12 months: change from baseline to six, and 12 months.
fracture and retention, marginal adaptation, form and contour, caries at the restoration margins, dental hard tissue defects, and postoperative hypersensitivity, surface luster and surface texture, marginal staining, and color match All these outcomes are measured using revised FDI criteria for clinical evaluation of restoration; where they will be given a score either excellent (1), good (2), satisfactory (3), unsatisfactory (4), or poor (5) - (acceptable = score 1 to 3, inacceptable but repair possible = score 4, and inacceptable but repair not possible/reasonable = score 5).
次要结局
未报告次要终点
研究者
Menna Omar El Ghamrawy
Assistant Lecturer
Cairo University
