Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Retention rate of restoration
研究概览
简要总结
The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.
详细描述
Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good oral hygiene
- •Absence of periodontal disease
- •Presence of at least 02 non-carious cervical lesions
排除标准
- •Presence of non-carious cervical lesion in non-vital teeth
- •Occlusal instability
- •Presence of orthodontic appliance
- •Presence of removable partial dental prosthesis
- •High risk of caries (presence of three or more active caries lesions)
- •Xerostomia
- •Patients allergic to base materials monomers
- •Patients who do not accept the project conditions
结局指标
主要结局
Retention rate of restoration
时间窗: 02 years
The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.
次要结局
- Marginal staining rate of restoration(02 years)
- Marginal Adaptation rate of restoration(02 years)
研究者
Cecy Martins Silva
Clinical professor
Universidade Federal do Para