Clinical Evaluation of Bulkfill-Composite Restorations Placed Using Different Techniques
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
- Marginal Discoloration
研究概览
简要总结
The objective of this study was to evaluate the clinical performance of a bulk-fill composite resin (3M ESPE Filtek Bulk Fill, St Paul, MN, USA) in restorations placed in occlusal cavities by comparing different placement techniques (bulk vs. incremental) using modified USPHS criteria.
详细描述
A total of 50 patients (n=108), each with two or four occlusal cavities having a depth of at least 4 mm, were randomly assigned to two groups. A bite-wing radiograph was taken for each tooth. The Single Bond Universal Adhesive (3M, ESPE, St Paul, MN, USA) was applied using the selective-enamel-etch mode. One tooth from each patient was restored using the bulk technique while the other was restored using the incremental technique. All restorations were placed by a single operator. Two experienced and calibrated examiners who were blinded to the placement technique evaluated the restorations at one week and subsequently at 6-, 12-, 24-, 36-, and 48-month follow-ups according to modified USPHS criteria. Spontaneous post-operative sensitivity was assessed through restorative procedures up to 24 hours post-treatment, as well as one week and six months later utilizing a Visual Analog Scale (VAS). The chi-square test was employed for comparing both restoration techniques within each category (p<0.05).
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
- 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
- •Good general health, 18 years of age or older, Acceptable oral hygiene level, Present at least 20 teeth in the occlusion, Have at least two or four posterior teeth in need of restorative treatment. Have carious lesions, defective restorations replacement due to esthetic reasons).
排除标准
- •Poor oral hygiene, Having possible allergy to resin-based restorations, Advanced periodontal disease, Xerostomia, Pregnancy or breastfeeding, Severe systemic disease, Diagnosis of bruxism, Bleaching treatment or orthodontic treatment.
研究组 & 干预措施
Group 2
Incremental placement technique
干预措施: incrementally technique (Procedure)
Group 1
Bulk-filling placement technique
干预措施: bulk tecnique (Procedure)
结局指标
主要结局
Marginal Discoloration
时间窗: From baseline to 6 year the change of restorations was evaluated
The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
Marginal Adaptation
时间窗: From baseline to 6 year the change of restorations was evaluated
Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
Color match
时间窗: From baseline to 2 year the change of restorations was evaluated
Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Post-op Hypersensitivity
时间窗: From baseline to 6 year the change of restorations was evaluated
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Secondary caries
时间窗: From baseline to 6 year the change of restorations was evaluated
Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable.
RETENTİON
时间窗: From baseline to 6 year the change of restorations was evaluated
The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent.
次要结局
未报告次要终点
研究者
A Ruya Yazici
professor
Hacettepe University