Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Restoration Percent Success at Year 1
研究概览
简要总结
Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years of age and older
- •Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
- •Be capable of giving written informed consent.
排除标准
- •Have a self-reported history of any adverse reaction to materials of the types to be evaluated
- •Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
结局指标
主要结局
Restoration Percent Success at Year 1
时间窗: Year 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre \[Item 1\] * Surface staining \[Item 2\] * Color stability and translucency \[Item 3\] * Anatomic form \[Item 4\] B.Functional Properties * Fractures and retention \[Item 5\] * Marginal adaptation \[Item 6\] * Wear \[Item 7\] * Contact point/food impact \[Item 8\] * Radiographic examination \[Item 9\] * Patient's view \[Item 10\] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality \[Item 11\] * Recurrence of caries, erosion, abfraction \[Item 12\] * Tooth integrity \[Item 13\] * Periodontal response \[Item 14\] * Adjacent mucosa \[Item 15\] * Oral and general health \[Item 16\]
Restoration Percent Success at Day 1
时间窗: Assessed immediately post restoration placement completion
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties Surface lustre \[Item 1\] Surface staining \[Item 2\] Color stability and translucency \[Item 3\] Anatomic form \[Item 4\] B.Functional Properties Fractures and retention \[Item 5\] Marginal adaptation \[Item 6\] Wear \[Item 7\] Contact point/food impact \[Item 8\] Radiographic examination \[Item 9\] Patient's view \[Item 10\] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality \[Item 11\] Recurrence of caries, erosion, abfraction \[Item 12\] Tooth integrity \[Item 13\] Periodontal response \[Item 14\] Adjacent mucosa \[Item 15\] Oral and general health \[Item 16\]
Restoration Percent Success at Year 2
时间窗: Year 2
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre \[Item 1\] * Surface staining \[Item 2\] * Color stability and translucency \[Item 3\] * Anatomic form \[Item 4\] B.Functional Properties * Fractures and retention \[Item 5\] * Marginal adaptation \[Item 6\] * Wear \[Item 7\] * Contact point/food impact \[Item 8\] * Radiographic examination \[Item 9\] * Patient's view \[Item 10\] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality \[Item 11\] * Recurrence of caries, erosion, abfraction \[Item 12\] * Tooth integrity \[Item 13\] * Periodontal response \[Item 14\] * Adjacent mucosa \[Item 15\] * Oral and general health \[Item 16\]
Restoration Percent Success at Year 3
时间窗: Year 3
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre \[Item 1\] * Surface staining \[Item 2\] * Color stability and translucency \[Item 3\] * Anatomic form \[Item 4\] B.Functional Properties * Fractures and retention \[Item 5\] * Marginal adaptation \[Item 6\] * Wear \[Item 7\] * Contact point/food impact \[Item 8\] * Radiographic examination \[Item 9\] * Patient's view \[Item 10\] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality \[Item 11\] * Recurrence of caries, erosion, abfraction \[Item 12\] * Tooth integrity \[Item 13\] * Periodontal response \[Item 14\] * Adjacent mucosa \[Item 15\] * Oral and general health \[Item 16\]
Restoration Percent Success at Year 5
时间窗: Year 5
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre \[Item 1\] * Surface staining \[Item 2\] * Color stability and translucency \[Item 3\] * Anatomic form \[Item 4\] B.Functional Properties * Fractures and retention \[Item 5\] * Marginal adaptation \[Item 6\] * Wear \[Item 7\] * Contact point/food impact \[Item 8\] * Radiographic examination \[Item 9\] * Patient's view \[Item 10\] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality \[Item 11\] * Recurrence of caries, erosion, abfraction \[Item 12\] * Tooth integrity \[Item 13\] * Periodontal response \[Item 14\] * Adjacent mucosa \[Item 15\] * Oral and general health \[Item 16\]
次要结局
未报告次要终点