Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- FDI World Dental Federation criteria
研究概览
简要总结
Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.
详细描述
Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.
This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.
Restorations will be evaluated clinically and radiographically according to FDI World Dental Federation criteria over 3-year period. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Significant loss of dental hard tissue
- •Endodontically treated teeth in posterior region
- •Replacement of large compromised existing restoration
- •Large Class II restoration
- •Age of 18-60 years
- •Good oral hygiene
- •Presence of interproximal contact to at least one neighboring teeth
- •In occlusion with antagonist teeth
- •Cavity preparation with at least one cuspal coverage
排除标准
- •Serious medical problems or allergies to substances and/or products to be used
- •Severe periodontal problems
- •Poor oral hygiene
- •Direct pulp capping
- •Presence of parafunctional behaviors
- •Pregnant or breast feeding
结局指标
主要结局
FDI World Dental Federation criteria
时间窗: at 3 years
Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
次要结局
未报告次要终点
研究者
Gulsah YENIER
Assist.Prof.
Okan University