Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in Retention rates of the restoration
研究概览
简要总结
This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.
The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.
详细描述
The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.
A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
- •Patients who had more than 20 teeth in the mouth;
- •Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
- •NCL in the facial surface of the teeth with sometimes a small part extending interproximally; Patients with good periodontal heath.
排除标准
- •Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
- •Tooth with the NCL with the absent of antagonist;
- •NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
- •Presence of caries or restorations in the area to be treated;
- •Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
- •Unwillingness to return for follow-ups or refuse to participate.
结局指标
主要结局
Change from baseline in Retention rates of the restoration
时间窗: 6, 12, 24, 36 and 60 months
Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention
次要结局
- Change from baseline in Post-operative sensitivity(6, 12, 24, 36 and 60 months)
- Change from baseline in marginal staining rates(6, 12, 24, 36 and 60 months)
研究者
Maximiliano Sergio Cenci
Professor
Federal University of Pelotas