Dentin Treatments for Restorations of Cervical Lesions Non-carious: a Randomized Clinical Trial of Three Years
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 主要终点
- Number of teeth with lost restorations
研究概览
简要总结
The surface of non-carious cervical lesions (LCNC) is a challenge to adhesive systems, it presents a dentin layer sclera hypermineralized, presence of bacteria and lack of mechanical retention, so this study aimed to evaluate the influence of different surface treatments on LCNC through a randomized clinical trial. Patients with LCNC were referred to the study and selected according to the inclusion criteria, such as the presence of at least 3 LCNC. Three different types of surface treatment were carried out in LCNC: control group, 15 seconds of etching dentin; Group I, acid etching of dentin in 30 seconds; and group II, cavity prophylaxis with ultrasound for 30 seconds. The remaining steps of the adhesive and restorative procedure was the same for all groups, following the material manufacturer's recommendations. Evaluations of restorations will be carried out in periods of one week (baseline), six months, one year, two years and three years as of tooth sensitivity, integrity and color change. Data will be analyzed by McNemar and chi-square test.
详细描述
Ethical considerations This study was designed and conducted according to the guidelines Consolidated Standards of Reporting of Trials (CONSORT) for the preparation of randomized controlled clinical trials (Altman et al., 2001), after approval by the Research Ethics Committee (protocol number CEP-035 -2011- FO / UFPel), Faculty of Dentistry, Federal University of Pelotas - RS / Brazil.
Study design
Calculation for determining the sample
Based on the literature, the sample size was obtained assuming an average annual rate of failure 6% for Class V restorations performed with conventional adhesive systems (PEUMANS et al., 2005b), with 80% power and significance level of 5%. From the recommendations of the American Dental Association (2010), we estimated an annual failure rate of 12% for restorations in relative isolation. For this, a sample of 28 was determined by monitoring patients for a minimum of 5 years, considering possible attrition of 20%.
Recruitment and selection of patients The search strategy of individuals interested in participating in this clinical trial was conducted through the dissemination of the project through the display of posters and distribution of pamphlets in FO / UFPEL as well as in basic health units (BHU) located in the urban area Pelotas. In addition, the study had the collaboration of students representatives of class associations, coordinating teachers of clinical activities and dentists the public health system, to increase the receptivity and the accession of potential volunteers.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of at least three non-carious cervical lesions on the buccal aspect of previous vital teeth or premolars;
- •Visible plaque index presence and / or gingival bleeding index of at most 20%;
- •Probing depth of at least 3 mm in the experimental site and / or buccal 4 mm in any place;
- •Patients with good general health condition;
- •Patients able to understand and sign the letter of information and the free and informed consent;
- •Patients willing to return every six months to revaluation queries.
排除标准
- •Presence of less than 20 teeth in the mouth;
- •Patients undergoing orthodontic treatment;
- •Patients with occlusion problems;
- •Veneers with wear over 50% of the incisal / occlusal structure;
- •Absence of tooth antagonist.
结局指标
主要结局
Number of teeth with lost restorations
时间窗: From Baseline restorations at 3 years
次要结局
- Presence or not of marginal leakage(From Baseline restorations at 3 years)
- Presence or not of dentin hypersensitivity(From Baseline restorations at 3 years)
研究者
Rafael Guerra Lund
Professor
Federal University of Pelotas