Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Esthetic Properties of restorations
研究概览
简要总结
The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.
详细描述
Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Good oral hygienic
- •Patient aging 18-35 year
- •Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
- •Carious lesion in the external and middle third of dentin thickness
- •ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
- •Maxillary or mandibular first or second molars
- •Tooth with antagonist and adjacent mesial and distal tooth contact,
- •Normal response to a vitality test.
排除标准
- •Poor oral hygiene
- •Severe or chronic periodontitis
- •Heavy bruxism
- •Occlusion fewer than 20 teeth
- •Sensitivity to resin-based material.
- •Patients with orthodontic treatment
- •Patients on pregnancy or lactation
- •chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
- •Patient potentially unable to attend recall visits
- •Teeth would need direct pulp capping or
- •Teeth act as abutment for fixed or removable prosthesis.
研究组 & 干预措施
Body Bulk-Fill
20 cavity class II restored with Body bulk-fill Resin composite
干预措施: Filtek™ Bulk Fill restoration (Other)
preheated Bulk-Fill
20 cavity class II restored with preheated bulk-fill Resin composite
干预措施: Heated Filtek™ Bulk Fill restoration (Other)
Injectable Bulk-Fill
20 cavity class II restored with injectable bulk-fill Resin composite
干预措施: G-aenial™ BULK Injectable restoration (Other)
Sonic-Fill
20 cavity class II restored with sonic-fill bulk-fill Resin composite
干预措施: Sonicfill3 restoration (Other)
结局指标
主要结局
Esthetic Properties of restorations
时间窗: Three years Follow up
criteria that evaluated according to Modified FDI(International Dental Federation) world dental federation is: 1. Surface luster 2. Staining 3. Color match and translucency 4. Esthetic and Anatomic form Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Functional Properties of restorations
时间窗: Three years Follow up
criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Fractures of material and retention 2. Marginal adaptation 3. Occlusal contour and wear 4. Proximal anatomical form 5. Patient's view Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Biological Properties of restorations
时间窗: Three years Follow up
criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Post-operative (hyper-sensitivity) and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal 5. Adjacent Mucosa 6. Oral and General Health Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
次要结局
未报告次要终点